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François, Pauline, Laurent Giraudo, Julie Veran, et al. "Development and Validation of a Fully GMP-Compliant Process for Manufacturing Stromal Vascular Fraction: A Cost-Effective Alternative to Automated Methods." Cells 9, no. 10 (2020): 2158. http://dx.doi.org/10.3390/cells9102158.
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The therapeutic use of adipose-derived stromal vascular fraction (SVF) is expanding in multiple pathologies. Various processes have been proposed for manufacturing SVF but they must be revisited based on advanced therapy medicinal product (ATMP) regulations. We report here the development and validation of a fully good manufacturing practices (GMP)-compliant protocol for the isolation of SVF. Adipose tissue was collected from healthy volunteers undergoing lipoaspiration. The optimal conditions of collagenase digestion and washing were determined based on measurements of SVF cell viability, yield recovery, and cell subset distribution. Comparability of the SVF obtained using the newly developed manufacturing process (n = 6) and the Celution-based automated method (n = 33), used as a reference, was established using inter-donor analyses. Characteristics of SVF (n = 5) generated using both manufacturing protocols were analyzed for an intra-donor comparison. In addition, these comparisons also included the determination of colony-forming unit fibroblast frequency, in vitro angiogenic activity, and in vivo regenerative effects in a mouse ischemic cutaneous wound model. We successfully developed a process for the generation of SVF presenting higher cell viability and yield recovery compared to the Celution device-based protocol. Characteristics of the SVF including phenotype, capacity for angiogenesis, and wound-healing promotion attested to the comparability of the two manufacturing processes. We validated an optimized non-automated process that should allow for a GMP-compliant, more affordable, and reduced-cost strategy to exploit the potential of SVF-based regenerative therapies.
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Ivanoska, Mena, Hristina Babunovska, and Rumenka Petkovska. "Functional risk assessment as part of the validation in the implementation of chromatography data system." Macedonian Pharmaceutical Bulletin 64, no. 01 (2018): 39–56. http://dx.doi.org/10.33320/maced.pharm.bull.2018.64.01.004.
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A Chromatography Data System (CDS) is a complex software that can be configured to the specific needs of the user’s business process. As such it falls into the Good Automated Manufacturing Practice (GAMP) 5 Category 4 – Configured Products. The validation process is planned and follows along the phases proposed by GAMP 5 for configured products. The Risk assessment stage of the CDS validation process is to carry out a risk assessment of each function of the User Requirements Specification (URS) determined on if the function is regulatory risk critical or not. The functional risk assessment is made according to the method- Failure Mode and Effects Analysis (FMEA). The Overall Risk resulting from the Risk Assessment has identified all potential failures requiring mitigating actions/controls. Mitigating actions and testing controls during the PQ phase is implemented. The final Overall Risk after implementation of Mitigating actions and testing controls during the PQ phase is not more than Medium. Keywords: chromatography data system, validation of the CDS Software, risk assessment, laboratory data integrity
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Clark, Andrew P. Z., Hong Dixon, Norma L. Cantu, Larry A. Cabell, and Joe A. McDonough. "Good Manufacturing Practice." International Journal of Toxicology 32, no. 4_suppl (2013): 18S—29S. http://dx.doi.org/10.1177/1091581813490204.
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We have established a current good manufacturing practice (GMP) manufacturing process to produce a nanoparticle suspension of 1,1′-methylenebis-4-[(hydroxyimino)methyl]pyridinium dimethanesulfonate (MMB4 DMS) in cottonseed oil (CSO) as a nerve agent antidote for a Phase 1 clinical trial. Bis-pyridinium oximes such as MMB4 were previously developed for emergency treatment of organophosphate nerve agent intoxication. Many of these compounds offer efficacy superior to monopyridinium oximes, but they have poor thermal stability due to hydrolytic cleavage in aqueous solution. We previously developed a nonaqueous nanoparticle suspension to improve the hydrothermal stability, termed Enhanced Formulation (EF). An example of this formulation technology is a suspension of MMB4 DMS nanoparticles in CSO. Due to the profound effect of particle size distribution on product quality and performance, particle size must be controlled during the manufacturing process. Therefore, a particle size analysis method for MMB4 DMS in CSO was developed and validated to use in support of good laboratory practice/GMP development and production activities. Manufacturing of EF was accomplished by milling MMB4 DMS with CSO and zirconia beads in an agitator bead mill. The resulting bulk material was filled into 5-mL glass vials at a sterile fill facility and terminally sterilized by gamma irradiation. The clinical lot was tested and released, a Certificate of Analysis was issued, and a 3-year International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) stability study started. The drug product was placed in storage for Phase 1 clinical trial distribution. A dose delivery uniformity study was undertaken to ensure that the correct doses were delivered to the patients in the clinic.
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Cunningham, Sarah, and Holger Hackstein. "Recent Advances in Good Manufacturing Practice-Grade Generation of Dendritic Cells." Transfusion Medicine and Hemotherapy 47, no. 6 (2020): 454–63. http://dx.doi.org/10.1159/000512451.
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Dendritic cells (DCs) are pivotal regulators of immune responses, specialized in antigen presentation and bridging the gap between the innate and adaptive immune system. Due to these key features, DCs have become a pillar of the continuously growing field of cellular therapies. Here we review recent advances in good manufacturing practice strategies and their individual specificities in relation to DC production for clinical applications. These take into account both small-scale experimental approaches as well as automated systems for patient care.
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Gastens, Martin H., Kristin Goltry, Wolfgang Prohaska, et al. "Good Manufacturing Practice-Compliant Expansion of Marrow-Derived Stem and Progenitor Cells for Cell Therapy." Cell Transplantation 16, no. 7 (2007): 685–96. http://dx.doi.org/10.3727/000000007783465172.
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Ex vivo expansion is being used to increase the number of stem and progenitor cells for autologous cell therapy. Initiation of pivotal clinical trials testing the efficacy of these cells for tissue repair has been hampered by the challenge of assuring safe and high-quality cell production. A strategy is described here for clinical-scale expansion of bone marrow (BM)-derived stem cells within a mixed cell population in a completely closed process from cell collection through postculture processing using sterile connectable devices. Human BM mononuclear cells (BMMNC) were isolated, cultured for 12 days, and washed postharvest using either standard open procedures in laminar flow hoods or using automated closed systems. Conditions for these studies were similar to long-term BM cultures in which hematopoietic and stromal components are cultured together. Expansion of marrow-derived stem and progenitor cells was then assessed. Cell yield, number of colony forming units (CFU), phenotype, stability, and multilineage differentiation capacity were compared from the single pass perfusion bioreactor and standard flask cultures. Purification of BMMNC using a closed Ficoll gradient process led to depletion of 98% erythrocytes and 87% granulocytes, compared to 100% and 70%, respectively, for manual processing. After closed system culture, mesenchymal progenitors, measured as CD105+CD166+CD14–CD45– and fibroblastic CFU, expanded 317- and 364-fold, respectively, while CD34+ hematopoietic progenitors were depleted 10-fold compared to starting BMMNC. Cultured cells exhibited multilineage differentiation by displaying adipogenic, osteogenic, and endothelial characteristics in vitro. No significant difference was observed between manual and bioreactor cultures. Automated culture and washing of the cell product resulted in 181 × 106 total cells that were viable and contained fibroblastic CFU for at least 24 h of storage. A combination of closed, automated technologies enabled production of good manufacturing practice (GMP)-compliant cell therapeutics, ready for use within a clinical setting, with minimal risk of microbial contamination.
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Shariatzadeh, Maryam, Amit Chandra, Samantha L. Wilson, et al. "Distributed automated manufacturing of pluripotent stem cell products." International Journal of Advanced Manufacturing Technology 106, no. 3-4 (2019): 1085–103. http://dx.doi.org/10.1007/s00170-019-04516-1.
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AbstractEstablishing how to effectively manufacture cell therapies is an industry-level problem. Decentralised manufacturing is of increasing importance, and its challenges are recognised by healthcare regulators with deviations and comparability issues receiving specific attention from them. This paper is the first to report the deviations and other risks encountered when implementing the expansion of human pluripotent stem cells (hPSCs) in an automated three international site–decentralised manufacturing setting. An experimental demonstrator project expanded a human embryonal carcinoma cell line (2102Ep) at three development sites in France, Germany and the UK using the CompacT SelecT (Sartorius Stedim, Royston, UK) automated cell culture platform. Anticipated variations between sites spanned material input, features of the process itself and production system details including different quality management systems and personnel. Where possible, these were pre-addressed by implementing strategies including standardisation, cell bank mycoplasma testing and specific engineering and process improvements. However, despite such measures, unexpected deviations occurred between sites including software incompatibility and machine/process errors together with uncharacteristic contaminations. Many only became apparent during process proving or during the process run. Further, parameters including growth rate and viability discrepancies could only be determined post-run, preventing ‘live’ corrective measures. The work confirms the critical nature of approaches usually taken in Good Manufacturing Practice (GMP) manufacturing settings and especially emphasises the requirement for monitoring steps to be included within the production system. Real-time process monitoring coupled with carefully structured quality systems is essential for multiple site working including clarity of decision-making roles. Additionally, an over-reliance upon post-process visual microscopic comparisons has major limitations; it is difficult for non-experts to detect deleterious culture changes and such detection is slow.
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Williams, David J., Robert J. Thomas, Paul C. Hourd, et al. "Precision manufacturing for clinical-quality regenerative medicines." Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences 370, no. 1973 (2012): 3924–49. http://dx.doi.org/10.1098/rsta.2011.0049.
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Innovations in engineering applied to healthcare make a significant difference to people's lives. Market growth is guaranteed by demographics. Regulation and requirements for good manufacturing practice—extreme levels of repeatability and reliability—demand high-precision process and measurement solutions. Emerging technologies using living biological materials add complexity. This paper presents some results of work demonstrating the precision automated manufacture of living materials, particularly the expansion of populations of human stem cells for therapeutic use as regenerative medicines. The paper also describes quality engineering techniques for precision process design and improvement, and identifies the requirements for manufacturing technology and measurement systems evolution for such therapies.
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Edwin, Tivany, Reinny Patrisina, Alexie Herryandie Bronto Adi, Prima Fithri, and Nindy Hidayah. "Pelatihan Good Manufacturing Practice (GMP) pada Usaha Pangan Binaan Universitas Andalas." Jurnal Warta Pengabdian Andalas 27, no. 1 (2020): 1–5. http://dx.doi.org/10.25077/jwa.27.1.1-5.2020.
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Food business is a very promising, but the products must be safe and worth buying. Good manufacturing practices (GMP) are production practices which considering various aspects, such as preventing food contamination during the production process, and production control as well. Small and Medium Enterprises (SME) fostered by Andalas University, which is engaged in the field of food manufacturing, wants to find its products better known and with a wide sales distribution. This can be realized if the business owner has the trust of many consumers. One effort that can be done is to implement the GMP For this reason, SMEs need to receive GMP Training.The method of this event is in the form of training to socialize the concept of GMP for food SMEs fostered by Andalas University, as well as self-assessment of the application of GMP that has been carried out by each SME. The training was held in the presence of 50 SMEs assisted by Andalas University, on Thursday / December 5, 2019 at Amaris Hotel, Padang. Participants were very enthusiastic in attending and actively participating during the training. Self assessment results showed most SMEs have not yet implemented a good GMP in their industry.
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Scur, Gabriela, Adriana Marotti de Mello, Lilian Schreiner, and Fernando José das Neves. "Eco-design requirements in heavyweight vehicle development – a case study of the impact of the Euro 5 emissions standard on the Brazilian industry." Innovation & Management Review 16, no. 4 (2019): 404–22. http://dx.doi.org/10.1108/inmr-08-2018-0063.
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Purpose The purpose of this paper is to investigate how technology-forcing regulations affect the product development process in the supply chain of heavyweight vehicles. Design/methodology/approach Through a case study, this paper seeks to understand how one of the leading companies in heavyweight vehicles manufacturing industry and its engine supplier in Brazil introduce eco-design practices into its engine development process. Findings Through case studies conducted in a heavyweight vehicle producer and its engine supplier, this study shows that, in addition to meeting the standards and legislation, the automaker uses ecodesign practices during the product development cycle such as a design that eliminates harmful and hazardous materials and a project that allows recycling, the reuse of parts and energy efficiency, thereby reducing the environmental impact. However, without the mandatory requirements imposed by federal legislation, products with lower environmental impacts would rarely be developed, as environmental performance is not demanded by customers, who are mainly cost driven. Technology-forcing regulations play an important role in enhancing the adoption of ecodesign practices, but market and competitive conditions also play an important role. Originality/value Several studies on the impacts of public policies and development for the automobile sector have been conducted, but there is a lack of studies in the area of commercial vehicles, especially in Brazil. Therefore, this research is justified by new demands of society, in addition to the necessity of complying with legal requirements and the adoption of good practices related to eco-design.
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Ziska, Sara M., John Schumacher, Sue H. Duran, and Kenny V. Brock. "Development of an automated plasmapheresis procedure for the harvest of equine plasma in accordance with current good manufacturing practice." American Journal of Veterinary Research 73, no. 6 (2012): 762–69. http://dx.doi.org/10.2460/ajvr.73.6.762.
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Kilic, Pelin, Meltem Bay, Pinar Baydin, et al. "Utility investigation of automated techniques in hematopoietic progenitor cell count and viability assessment in the Good Manufacturing Practice (GMP) setting." Experimental Biomedical Research 3, no. 4 (2020): 231–38. http://dx.doi.org/10.30714/j-ebr.2020463606.
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Pyatigorskaya, N. V., V. V. Beregovykh, Zh I. Aladysheva, Vasiliy V. Belyaev, A. P. Meshkovskii, and A. M. Pyatigorskii. "AUTOMATED DOCUMENT MANAGEMENT SYSTEM OF PHARMACEUTICAL MANUFACTURER’S QUALITY MANAGEMENT SYSTEM IN ACCORDANCE WITH REQUIREMENTS OF GMP." Annals of the Russian academy of medical sciences 72, no. 2 (2017): 126–33. http://dx.doi.org/10.15690/vramn808.
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Drugs must be produced in compliance with good manufacturing practice rules approved by an authorized federal agency. Pharmaceutical Quality System is a global requirement for development and production processes for pharmaceutical products. The article describes a variant of automated document management system of pharmaceutical manufacturer’s quality management system in accordance with current requirements of GMP. The peculiarity of the proposed system is the focuses on pharmaceutical production taking into account the characteristics and requirements for the pharmaceutical products production. All documents which are supposed to be used within the system are grouped into the four blocks: normative legal acts, core manufacturer standards according to GMP, regulatory documents, and register documents.
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Berstad, Maria E. B., Lawrence H. Cheung, and Anette Weyergang. "Production of Recombinant Gelonin Using an Automated Liquid Chromatography System." Toxins 12, no. 8 (2020): 519. http://dx.doi.org/10.3390/toxins12080519.
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Advances in recombinant DNA technology have opened up new possibilities of exploiting toxic proteins for therapeutic purposes. Bringing forth these protein toxins from the bench to the bedside strongly depends on the availability of production methods that are reproducible, scalable and comply with good manufacturing practice (GMP). The type I ribosome-inhibiting protein, gelonin, has great potential as an anticancer drug, but is sequestrated in endosomes and lysosomes. This can be overcome by combination with photochemical internalization (PCI), a method for endosomal drug release. The combination of gelonin-based drugs and PCI represents a tumor-targeted therapy with high precision and efficiency. The aim of this study was to produce recombinant gelonin (rGel) at high purity and quantity using an automated liquid chromatography system. The expression and purification process was documented as highly efficient (4.4 mg gelonin per litre induced culture) and reproducible with minimal loss of target protein (~50% overall yield compared to after initial immobilized metal affinity chromatography (IMAC)). The endotoxin level of 0.05–0.09 EU/mg was compatible with current standards for parenteral drug administration. The automated system provided a consistent output with minimal human intervention and close monitoring of each purification step enabled optimization of both yield and purity of the product. rGel was shown to have equivalent biological activity and cytotoxicity, both with and without PCI-mediated delivery, as rGelref produced without an automated system. This study presents a highly refined and automated manufacturing procedure for recombinant gelonin at a quantity and quality sufficient for preclinical evaluation. The methods established in this report are in compliance with high quality standards and compose a solid platform for preclinical development of gelonin-based drugs.
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Toktonalieva, N., and I. Toktonaliev. "History and Background of the Implementation of Good Manufacturing Practice Standards in the Pharmaceutical Industry (Review)." Bulletin of Science and Practice 6, no. 9 (2020): 182–91. http://dx.doi.org/10.33619/2414-2948/58/17.
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The volume of the global pharmaceutical market in 2018 amounted to 1.2 trillion US dollars, and by 2020 the global pharmaceutical market has grown to 1.5 trillion dollars. Countries such as the United States, Japan, Germany, Switzerland and Great Britain took the leading positions in the pharmaceutical market, while the market share of the member states of the Eurasian Economic Union (EAEU) in the world community was 2.6%. Further growth of the global pharmaceutical market is predicted by 5% annually, which may contribute to the rapid production and distribution of low-quality pharmaceutical products. One of the main goals of the country is to provide the population with effective, high-quality and safe medicines drugs to protect their health, since consumers cannot assess the quality of medicines on their own. To accomplish this task in developed and developing countries, the state regularly checks and evaluates the quality, efficacy, safety, as well as the main pharmacological effects of drugs at all stages of production. In the production of drugs, it is necessary to comply with the rules of Good Manufacturing Practice. Good Manufacturing Practice is one of the indispensable elements of a modern control and authorization system in the field of pharmaceutical circulation, no less important than the Pharmacopoeia or other state drug standards. Materials and methods. The review article presents an analysis of published scientific works of the last 15 years. To search for reliable information, we used scientific literature data from available and open sources placed in scientific electronic databases: Cyberleninka, PubMed, E-library, Medline, J-stage, Hindawi using the keywords: Good Manufacturing Practice, GMP, pharmaceutical industry, quality of medicines. Results. When analyzing scientific literature sources, special attention is paid to the relevance of this problem, the prerequisites for the introduction of Good Manufacturing Practice standards in the pharmaceutical industry and world practice. Conclusion. Summarizing the scientific literature data, we came to the conclusion that it is necessary to comply with the basic requirements of the international Good Manufacturing Practice standard for the production of high-quality drugs, which has a positive effect on the health of consumers.
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Wagner, Michael, Johan G. Doverfjord, Joachim Tillner, et al. "Automated GMP-Compliant Production of [68Ga]Ga-DO3A-Tuna-2 for PET Microdosing Studies of the Glucagon Receptor in Humans." Pharmaceuticals 13, no. 8 (2020): 176. http://dx.doi.org/10.3390/ph13080176.
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Introduction: [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 (previously published as [68Ga]Ga-DO3A-VS-Cys40-S01-GCG) has shown high-affinity specific binding to the glucagon receptor (GCGR) in vitro and in vivo in rats and non-human primates in our previous studies, confirming the suitability of the tracer for drug development applications in humans. The manufacturing process of [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 was automated for clinical use to meet the radiation safety and good manufacturing practice (GMP) requirements. Methods: The automated synthesis platform (Modular-Lab PharmTrace, Eckert & Ziegler, Eurotope, Germany), disposable cassettes for 68Ga-labeling, and pharmaceutical-grade 68Ge/68Ga generator (GalliaPharm®) used in the study were purchased from Eckert & Ziegler. The parameters such as time, temperature, precursor concentration, radical scavenger, buffer concentration, and pH, as well as product purification step, were investigated and optimized. Process optimization was conducted with regard to product quality and quantity, as well as process reproducibility. The active pharmaceutical ingredient starting material DO3A-VS-Cys40-Tuna-2 (GMP-grade) was provided by Sanofi Aventis. Results: The reproducible and GMP-compliant automated production of [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 with on-line documentation was developed. The non-decay-corrected radiochemical yield was 45.2 ± 2.5% (n = 3, process validation) at the end of the synthesis with a labeling synthesis duration of 38 min and a quality controlincluding release procedure of 20 min. The radiochemical purity of the product was 98.9 ± 0.6% (n = 17) with the total amount of the peptide in the preparation of 48 ± 2 µg (n = 3, process validation). Radionuclidic purity, sterility, endotoxin content, residual solvent content, and sterile filter integrity tests met the acceptance criteria. The product was stable at ambient temperature for at least 2 h. Conclusion: The fully automated GMP-compliant manufacturing process was developed and thoroughly validated. The resulting [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 was used in a clinical study for accurate quantification of GCGR occupancy by a dual anti-diabetic drug in vivo in humans.
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Shin, Youngbin, Kyung Won Kim, Amy Junghyun Lee, et al. "A Good Practice–Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study." JMIR Medical Informatics 7, no. 3 (2019): e14310. http://dx.doi.org/10.2196/14310.
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Background With the rapid increase in utilization of imaging endpoints in multicenter clinical trials, the amount of data and workflow complexity have also increased. A Clinical Trial Imaging Management System (CTIMS) is required to comprehensively support imaging processes in clinical trials. The US Food and Drug Administration (FDA) issued a guidance protocol in 2018 for appropriate use of medical imaging in accordance with many regulations including the Good Clinical Practice (GCP) guidelines. Existing research on CTIMS, however, has mainly focused on functions and structures of systems rather than regulation and compliance. Objective We aimed to develop a comprehensive CTIMS to meet the current regulatory guidelines and various required functions. We also aimed to perform computerized system validation focusing on the regulatory compliance of our CTIMS. Methods Key regulatory requirements of CTIMS were extracted thorough review of many related regulations and guidelines including International Conference on Harmonization-GCP E6, FDA 21 Code of Federal Regulations parts 11 and 820, Good Automated Manufacturing Practice, and Clinical Data Interchange Standards Consortium. The system architecture was designed in accordance with these regulations by a multidisciplinary team including radiologists, engineers, clinical trial specialists, and regulatory medicine professionals. Computerized system validation of the developed CTIMS was performed internally and externally. Results Our CTIMS (AiCRO) was developed based on a two-layer design composed of the server system and the client system, which is efficient at meeting the regulatory and functional requirements. The server system manages system security, data archive, backup, and audit trail. The client system provides various functions including deidentification, image transfer, image viewer, image quality control, and electronic record. Computerized system validation was performed internally using a V-model and externally by a global quality assurance company to demonstrate that AiCRO meets all regulatory and functional requirements. Conclusions We developed a Good Practice–compliant CTIMS—AiCRO system—to manage large amounts of image data and complexity of imaging management processes in clinical trials. Our CTIMS adopts and adheres to all regulatory and functional requirements and has been thoroughly validated.
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Ghodsizad, Ali, Viktor Bordel, Brian Bruckner, et al. "Clinical Labeling and Imaging of Transplanted CD133+/CD34+ Stem Cells in Patients with Ischemic Heart Disease." Heart Surgery Forum 15, no. 2 (2012): 116. http://dx.doi.org/10.1532/hsf98.20111138.
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The application of somatic stem cells has been shown to support the recovery of the myocardium in end-stage heart failure. A novel method for the intraoperative isolation and labeling of bone marrow-derived stem cells was established. After induction of general anesthesia, up to 400 mL of bone marrow were harvested from the posterior iliac crest and processed in the operating room under good manufacturing practice conditions by means of the automated cell-selection device Clini-MACS (Miltenyi Biotec). We subsequently injected autologous CD133<sup>+</sup> and CD34<sup>+</sup> stem cells in a predefined pattern around the laser channels in patients undergoing coronary artery bypass surgery and transmyocardial laser procedures. Intraoperative isolation and labeling is an effective cell-separation tool for the future, considering that novel cell markers can be promising new candidates for cell therapy.
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Lisini, Daniela, Sara Nava, Simona Frigerio, et al. "Automated Large-Scale Production of Paclitaxel Loaded Mesenchymal Stromal Cells for Cell Therapy Applications." Pharmaceutics 12, no. 5 (2020): 411. http://dx.doi.org/10.3390/pharmaceutics12050411.
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Mesenchymal stromal cells (MSCs) prepared as advanced therapies medicinal products (ATMPs) have been widely used for the treatment of different diseases. The latest developments concern the possibility to use MSCs as carrier of molecules, including chemotherapeutic drugs. Taking advantage of their intrinsic homing feature, MSCs may improve drugs localization in the disease area. However, for cell therapy applications, a significant number of MSCs loaded with the drug is required. We here investigate the possibility to produce a large amount of Good Manufacturing Practice (GMP)-compliant MSCs loaded with the chemotherapeutic drug Paclitaxel (MSCs-PTX), using a closed bioreactor system. Cells were obtained starting from 13 adipose tissue lipoaspirates. All samples were characterized in terms of number/viability, morphology, growth kinetics, and immunophenotype. The ability of MSCs to internalize PTX as well as the antiproliferative activity of the MSCs-PTX in vitro was also assessed. The results demonstrate that our approach allows a large scale expansion of cells within a week; the MSCs-PTX, despite a different morphology from MSCs, displayed the typical features of MSCs in terms of viability, adhesion capacity, and phenotype. In addition, MSCs showed the ability to internalize PTX and finally to kill cancer cells, inhibiting the proliferation of tumor lines in vitro. In summary our results demonstrate for the first time that it is possible to obtain, in a short time, large amounts of MSCs loaded with PTX to be used in clinical trials for the treatment of patients with oncological diseases.
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Medushevskiy, Sergii. "AUTOMATED INFORMATION SYSTEMS AS ELEMENTS OF THE PHARMACEUTICAL ENTERPRISE QUALITY MANAGEMENT SYSTEM." Technical Sciences and Technologies, no. 4(22) (2020): 65–71. http://dx.doi.org/10.25140/2411-5363-2020-4(22)-65-71.
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Urgency of the research. With the development of information technology and new management practices, there has been a convergence and often a merger of quality management and information technology practices. At present, concepts based on the integration of quality management systems and automated information systems are becoming increasingly important.Actual scientific researches and issues analysis.In the process of researching specialized scientific and technical litera-ture, modern trends and problems of introduction of information technologies in the quality management system were analyzed.Uninvestigated parts of general matters defining. An unsolved problem is to ensure the quality of use of automated infor-mation systems at a pharmaceutical enterprise integrated into an enterprise quality management system based on the requirements of the international GMP standard and the Guidelines ST-N MOH 42-4.0: 2016 “Medicines. Good manufacturing practice".The research objective. The purpose is to systematically analyze the methodological foundations of quality assurance, through the introduction and use of AIS, aimed at creating favorable conditions for improving the efficiency of the quality management system in the pharmaceutical industry.The statement of basic materials. The issues of construction and improvement of quality management system based on existing technologies for automated production are considered. The structure of the computer quality management system and the mechanisms of its information support are determined. The methods of integration of specialized software systems are alsoanalyzed and the concept of integration of them into the quality management system is proposed.Conclusions.Based on the critical analysis, a number of unresolved problems related to the development, implementation and use of automated information systems based on international standards were separated, as well as the scientific hypothesis of the effective implementation and use of automated information systems integrated into the quality management system of the pharmaceutical enterprise was put forward.
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Jou, Josep M., Fulgencio Navalón, Rosario García, et al. "Neutrophil CD64 Is a Good Indicator of Infection and Sepsis." Blood 114, no. 22 (2009): 1347. http://dx.doi.org/10.1182/blood.v114.22.1347.1347.
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Abstract Abstract 1347 Poster Board I-369 Introduction Sepsis is among the top 10 causes of death, but improvements in the diagnostic tests for detecting and monitoring sepsis and infection have been limited in the last years. Neutrophil CD64 expression increases rapidly in the presence of inflammation mediators and in response to infection and tissue damage. We have evaluated changes in the expression of neutrophil CD64 in infected patients in comparison with other markers of infection and sepsis. Methods Prospective analysis of 56 blood samples from patients from the intensive care unit at our institution was performed for neutrophil CD64 expression, C-reactive protein (CRP), automated absolute neuthophil count (ANC), and complete manual leucocyte formula including % of bands (BANDS), and % of metamyelocytes and myelocytes (IG). Neutrophil CD64 expression was measured by flow cytometry using a quantitative method (Leuko64TM, Trillium Diagnostics, LLC). Patients were categorized into 5 groups (CLINIC) based on the clinical history and the degree of a systemic inflammatory response, from 1 (no inflammation) to 5 (septic shock). Statistics were performed using linear regression, correlation coefficient, and Passing-Bablock (P-B) regression. Sensitivity (S), specificity (SP), efficiency (E), and positive and negative predictive values (PPV and NPV respectively) were analyzed for all the parameters measured. Results Our results showed a correlation with CLINIC of 0.417, 0.552, 0.268, and 0.136 for CD64, CRP, BANDS, and ANC, respectively. P-B regression was only good for CD64, with a slope of 1.03 (0.6-1.4). Percentages (%) of S, SP, E, PPV, and NPV for CD64 were of 81%, 72%, 71%, 46% and 92%, respectively for groups 4 and 5. For CRP, S was of 93% with SP of 20%, E of 38%, PPV of 27%, and NPV of 91%. The remaining parameters showed deficient correlation with CLINIC. Correlations between CD64 and CRP, BANDS, and ANC were of 0.435, 0.342, and 0.01, respectively. Conclusions Neutrophil CD64 expression quantitation provides improved diagnostic detection of infection/sepsis compared with the standard diagnostic tests used in current medical practice. CD64 expression showed a better PPV than CRP, and an acceptable NPV. CRP showed deficient SP and E. BANDS, GI, and ANC showed no correlation with CLINIC. CD64 is a new indicator of infection that deserves consideration to be introduced in the daily hematology laboratory analysis. Disclosures No relevant conflicts of interest to declare.
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Pendrill, L. R., A. Allard, N. Fischer, P. M. Harris, J. Nguyen, and I. M. Smith. "Software to Maximize End-User Uptake of Conformity Assessment With Measurement Uncertainty, Including Bivariate Cases. The European EMPIR CASoft Project." NCSL International Measure 13, no. 1 (2021): 58–69. http://dx.doi.org/10.51843/measure.13.1.6.
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Facilitating the uptake of established methodologies for risk-based decision-making in product conformity assessment taking into account measurement uncertainty by providing dedicated software is the aim of the European project EMPIR CASoft(2018–2020), involving the National Measurement Institutes from France, Sweden and the UK, and industrial partner Trescal (FR) as primary supporter. The freely available software helps end-users perform the required risk calculations in accordance with current practice and regulations and extends that current practice to include bivariate cases. The software is also aimed at supporting testing and calibration laboratories in the application of the latest version of the ISO/IEC 17025:2017 standard, which requires that“…the laboratory shall document the decision rule employed, taking into account the level of risk […] associated with the decision rule and apply the decision rule.” Initial experiences following launch of the new software in Spring 2020 are reported.
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Schwitzguebel, Adrien Jean-Pierre, Clarisse Jeckelmann, Roberto Gavinio, Cécile Levallois, Charles Benaïm, and Hervé Spechbach. "Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History–Taking Device: Pilot Randomized Controlled Trial." JMIR Medical Informatics 7, no. 4 (2019): e14044. http://dx.doi.org/10.2196/14044.
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Background Automated medical history–taking devices (AMHTDs) are emerging tools with the potential to increase the quality of medical consultations by providing physicians with an exhaustive, high-quality, standardized anamnesis and differential diagnosis. Objective This study aimed to assess the effectiveness of an AMHTD to obtain an accurate differential diagnosis in an outpatient service. Methods We conducted a pilot randomized controlled trial involving 59 patients presenting to an emergency outpatient unit and suffering from various conditions affecting the limbs, the back, and the chest wall. Resident physicians were randomized into 2 groups, one assisted by the AMHTD and one without access to the device. For each patient, physicians were asked to establish an exhaustive differential diagnosis based on the anamnesis and clinical examination. In the intervention group, residents read the AMHTD report before performing the anamnesis. In both the groups, a senior physician had to establish a differential diagnosis, considered as the gold standard, independent of the resident’s opinion and AMHTD report. Results A total of 29 patients were included in the intervention group and 30 in the control group. Differential diagnosis accuracy was higher in the intervention group (mean 75%, SD 26%) than in the control group (mean 59%, SD 31%; P=.01). Subgroup analysis showed a between-group difference of 3% (83% [17/21]-80% [14/17]) for low complexity cases (1-2 differential diagnoses possible) in favor of the AMHTD (P=.76), 31% (87% [13/15]-56% [18/33]) for intermediate complexity (3 differential diagnoses; P=.02), and 24% (63% [34/54]-39% [14/35]) for high complexity (4-5 differential diagnoses; P=.08). Physicians in the intervention group (mean 4.3, SD 2) had more years of clinical practice compared with the control group (mean 5.5, SD 2; P=.03). Differential diagnosis accuracy was negatively correlated to case complexity (r=0.41; P=.001) and the residents’ years of practice (r=0.04; P=.72). The AMHTD was able to determine 73% (SD 30%) of correct differential diagnoses. Patient satisfaction was good (4.3/5), and 26 of 29 patients (90%) considered that they were able to accurately describe their symptomatology. In 8 of 29 cases (28%), residents considered that the AMHTD helped to establish the differential diagnosis. Conclusions The AMHTD allowed physicians to make more accurate differential diagnoses, particularly in complex cases. This could be explained not only by the ability of the AMHTD to make the right diagnoses, but also by the exhaustive anamnesis provided.
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Herigon, Joshua C., Amir Kimia, and Marvin Harper. "1358. Using natural language processing to optimize case ascertainment of acute otitis media in a large, state-wide pediatric practice network." Open Forum Infectious Diseases 7, Supplement_1 (2020): S690—S691. http://dx.doi.org/10.1093/ofid/ofaa439.1540.
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Abstract Background Antibiotics are the most commonly prescribed drugs for children and frequently inappropriately prescribed. Outpatient antimicrobial stewardship interventions aim to reduce inappropriate antibiotic use. Previous work has relied on diagnosis coding for case identification which may be inaccurate. In this study, we sought to develop automated methods for analyzing note text to identify cases of acute otitis media (AOM) based on clinical documentation. Methods We conducted a cross-sectional retrospective chart review and sampled encounters from 7/1/2018 – 6/30/2019 for patients &lt; 5 years old presenting for a problem-focused visit. Complete note text and limited structured data were extracted for 12 randomly selected weekdays (one from each month during the study period). An additional weekday was randomly selected for validation. The primary outcome was correctly identifying encounters where AOM was present. Human review was considered the “gold standard” and was compared to ICD codes, a natural language processing (NLP) model, and a recursive partitioning (RP) model. Results A total of 2,724 encounters were included in the training cohort and 793 in the validation cohort. ICD codes and NLP had good performance overall with sensitivity 91.2% and 93.1% respectively in the training cohort. However, NLP had a significant drop-off in performance in the validation cohort (sensitivity: 83.4%). The RP model had the highest sensitivity (97.2% training cohort; 94.1% validation cohort) out of the 3 methods. Figure 1. Details of encounters included in the training and validation cohorts. Table 1. Performance of ICD coding, a natural language processing (NLP) model, and a recursive partitioning (RP) model for identifying cases of acute otitis media (AOM) Conclusion Natural language processing of outpatient pediatric visit documentation can be used successfully to create models accurately identifying cases of AOM based on clinical documentation. Combining NLP and structured data can improve automated case detection, leading to more accurate assessment of antibiotic prescribing practices. These techniques may be valuable in optimizing outpatient antimicrobial stewardship efforts. Disclosures All Authors: No reported disclosures
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Querdel, Eva, Marina Reinsch, Liesa Castro, et al. "Human Engineered Heart Tissue Patches Remuscularize the Injured Heart in a Dose-Dependent Manner." Circulation 143, no. 20 (2021): 1991–2006. http://dx.doi.org/10.1161/circulationaha.120.047904.
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Background: Human engineered heart tissue (EHT) transplantation represents a potential regenerative strategy for patients with heart failure and has been successful in preclinical models. Clinical application requires upscaling, adaptation to good manufacturing practices, and determination of the effective dose. Methods: Cardiomyocytes were differentiated from 3 different human induced pluripotent stem cell lines including one reprogrammed under good manufacturing practice conditions. Protocols for human induced pluripotent stem cell expansion, cardiomyocyte differentiation, and EHT generation were adapted to substances available in good manufacturing practice quality. EHT geometry was modified to generate patches suitable for transplantation in a small-animal model and perspectively humans. Repair efficacy was evaluated at 3 doses in a cryo-injury guinea pig model. Human-scale patches were epicardially transplanted onto healthy hearts in pigs to assess technical feasibility. Results: We created mesh-structured tissue patches for transplantation in guinea pigs (1.5×2.5 cm, 9–15×10 6 cardiomyocytes) and pigs (5×7 cm, 450×10 6 cardiomyocytes). EHT patches coherently beat in culture and developed high force (mean 4.6 mN). Cardiomyocytes matured, aligned along the force lines, and demonstrated advanced sarcomeric structure and action potential characteristics closely resembling human ventricular tissue. EHT patches containing ≈4.5, 8.5, 12×10 6 , or no cells were transplanted 7 days after cryo-injury (n=18–19 per group). EHT transplantation resulted in a dose-dependent remuscularization (graft size: 0%–12% of the scar). Only high-dose patches improved left ventricular function (+8% absolute, +24% relative increase). The grafts showed time-dependent cardiomyocyte proliferation. Although standard EHT patches did not withstand transplantation in pigs, the human-scale patch enabled successful patch transplantation. Conclusions: EHT patch transplantation resulted in a partial remuscularization of the injured heart and improved left ventricular function in a dose-dependent manner in a guinea pig injury model. Human-scale patches were successfully transplanted in pigs in a proof-of-principle study.
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Blaeschke, Franziska, Dana Stenger, Theresa Kaeuferle, et al. "Induction of a central memory and stem cell memory phenotype in functionally active CD4+ and CD8+ CAR T cells produced in an automated good manufacturing practice system for the treatment of CD19+ acute lymphoblastic leukemia." Cancer Immunology, Immunotherapy 67, no. 7 (2018): 1053–66. http://dx.doi.org/10.1007/s00262-018-2155-7.
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Uslu, Ugur, Michael Erdmann, Manuel Wiesinger, Gerold Schuler, and Beatrice Schuler-Thurner. "Automated Good Manufacturing Practice–compliant generation of human monocyte-derived dendritic cells from a complete apheresis product using a hollow-fiber bioreactor system overcomes a major hurdle in the manufacture of dendritic cells for cancer vaccines." Cytotherapy 21, no. 11 (2019): 1166–78. http://dx.doi.org/10.1016/j.jcyt.2019.09.001.
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Amalia, Diah, and Steven Ferdiansyah. "Does Political Connection, Executive Character, and Audit Quality Affect the Tax Avoidance Practice? Evidence in Indonesia." Sebelas Maret Business Review 4, no. 2 (2019): 93. http://dx.doi.org/10.20961/smbr.v4i2.35905.
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<p class="Abstract">This study aims to know and find empirical evidence about the effect of political connection, executive characters, and audit quality on tax avoidance practice in Indonesia. This research uses secondary data with database collection technique using annual report of the manufacturing companies that are listed in Indonesian Stock Exchange (IDX) period 2013 – 2017. Using purposive sampling, this study obtained 51 companies which fulfill the criteria of 165 companies as total population, so the total observation for 5 years is 255 samples. The data examination in this study uses multiple regression analysis with data panel. Tax avoidance practice in this research proxied by Cash ETR. The results of this study indicate that variable political connection has significant positive effect on tax avoidance, which means that the average company uses their political connections to lower tax payments. Variable executive characters has no significant effect on tax avoidance, which means that the characters of executive not yet able to become a standard to determining tax avoidance practice. Variable audit quality indicated no significant effect on tax avoidance, which means KAP the big four who has a good quality hasn’t been able to conclude the company not doing tax avoidance practice.</p>
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Ford, Elizabeth, Johannes Starlinger, Philip Rooney, et al. "Could dementia be detected from UK primary care patients’ records by simple automated methods earlier than by the treating physician? A retrospective case-control study." Wellcome Open Research 5 (June 8, 2020): 120. http://dx.doi.org/10.12688/wellcomeopenres.15903.1.
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Background: Timely diagnosis of dementia is a policy priority in the United Kingdom (UK). Primary care physicians receive incentives to diagnose dementia; however, 33% of patients are still not receiving a diagnosis. We explored automating early detection of dementia using data from patients’ electronic health records (EHRs). We investigated: a) how early a machine-learning model could accurately identify dementia before the physician; b) if models could be tuned for dementia subtype; and c) what the best clinical features were for achieving detection. Methods: Using EHRs from Clinical Practice Research Datalink in a case-control design, we selected patients aged >65y with a diagnosis of dementia recorded 2000-2012 (cases) and matched them 1:1 to controls; we also identified subsets of Alzheimer’s and vascular dementia patients. Using 77 coded concepts recorded in the 5 years before diagnosis, we trained random forest classifiers, and evaluated models using Area Under the Receiver Operating Characteristic Curve (AUC). We examined models by year prior to diagnosis, subtype, and the most important features contributing to classification. Results: 95,202 patients (median age 83y; 64.8% female) were included (50% dementia cases). Classification of dementia cases and controls was poor 2-5 years prior to physician-recorded diagnosis (AUC range 0.55-0.65) but good in the year before (AUC: 0.84). Features indicating increasing cognitive and physical frailty dominated models 2-5 years before diagnosis; in the final year, initiation of the dementia diagnostic pathway (symptoms, screening and referral) explained the sudden increase in accuracy. No substantial differences were seen between all-cause dementia and subtypes. Conclusions: Automated detection of dementia earlier than the treating physician may be problematic, if using only primary care data. Future work should investigate more complex modelling, benefits of linking multiple sources of healthcare data and monitoring devices, or contextualising the algorithm to those cases that the GP would need to investigate.
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Kameník, J., A. Saláková, G. Bořilová, Z. Pavlík, E. Standarová, and L. Steinhauser. "Effect of storage temperature on the quality of dry fermented sausage Poličan." Czech Journal of Food Sciences 30, No. 4 (2012): 293–301. http://dx.doi.org/10.17221/284/2011-cjfs.
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The influence of different storage temperatures (5&deg;C and 15&deg;C) on the quality of vacuum-packed dry fermented sausage Poličan was determined. The salami mixture, finished salamis (the maturing period of 30 days), and salamis stored for 30, 60, 90, and 120 days were analysed. The analyses performed (physical/chemical, sensory, microbiological) found no differences in sensory properties or basic physical/chemical and microbiological parameters in the products after storage under different temperature conditions for 120 days. When stored at 15&deg;C, the total content of biogenic amines in samples was higher than that for samples stored at 5&deg;C with statistical differences P &le; 0.05. If the principles of good manufacturing practice are observed at all phases of the technological process, the storage temperature of 15&deg;C does not represent a risk as the consequent concentration of biogenic amines and polyamines remains extremely low. &nbsp;
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Li, Yuanyuan, Stefano Carabelli, Edoardo Fadda, Daniele Manerba, Roberto Tadei, and Olivier Terzo. "Machine learning and optimization for production rescheduling in Industry 4.0." International Journal of Advanced Manufacturing Technology 110, no. 9-10 (2020): 2445–63. http://dx.doi.org/10.1007/s00170-020-05850-5.
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Abstract Along with the fourth industrial revolution, different tools coming from optimization, Internet of Things, data science, and artificial intelligence fields are creating new opportunities in production management. While manufacturing processes are stochastic and rescheduling decisions need to be made under uncertainty, it is still a complicated task to decide whether a rescheduling is worthwhile, which is often addressed in practice on a greedy basis. To find a tradeoff between rescheduling frequency and the growing accumulation of delays, we propose a rescheduling framework, which integrates machine learning (ML) techniques and optimization algorithms. To prove the effectiveness, we first model a flexible job-shop scheduling problem with sequence-dependent setup and limited dual resources (FJSP) inspired by an industrial application. Then, we solve the scheduling problem through a hybrid metaheuristic approach. We train the ML classification model for identifying rescheduling patterns. Finally, we compare its rescheduling performance with periodical rescheduling approaches. Through observing the simulation results, we find the integration of these techniques can provide a good compromise between rescheduling frequency and scheduling delays. The main contributions of the work are the formalization of the FJSP problem, the development of ad hoc solution methods, and the proposal/validation of an innovative ML and optimization-based framework for supporting rescheduling decisions.
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S.І., Bilyk, and Bilyk А.S. "MAIN DIRECTIONS OF MODERN DEVELOPMENT OF STEEL CONSTRUCTIONS FOR BUILDINGS AND STRUCTURES." Modern structures of metal and wood, no. 25 (August 2021): 5–12. http://dx.doi.org/10.31650/2707-3068-2021-25-5-12.
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The development of technologies for the manufacture and design of steel structures, together with the development of computer technologies, makes it possible to increase productivity in the building industry. The analysis and generalization of such factors made it possible to identify the main trends and directions of the creation and improvement of metal structures, taking into account the automation of their manufacturing processes and the use of BIM technologies. The highlighted tendencies make it possible to show both new directions for the development of scientific research and directions for the development of practical methodologies for determining the regularities of the stress-strain state of structural systems using steel. Among the main trends, the following are highlighted: digitalization of the metal construction industry; automation and robotization of the manufacturing and assembling processes; science intensity of design and production processes; greening production, evaluating design solutions from the standpoint of environmental safety; complex optimization of design solutions. The authors highlight the next important tasks and prospects for the development of the creation of effective metal structures: the creation and use of high-strength steels C960 and more, the improvement of automated and robotic welding processes for ultra-high-strength steels with various metal thicknesses; development and improvement of the theory of calculation of thin-walled and composite structures, determination of the actual resource of metal structures after long-term operation; introduction into the practice of creating new structures of rational and optimal design approaches with the requirements of long-term operation and life cycle, including progressive collapse, reduction in the cost of fire and anti-corrosion covers for steel structures; improvement of building codes and rules for the design of metal structures; implementation of leading foreign standards and experience; training of modern professional engineers and technicians; development of experimental and theoretical studies of full-scale samples of structures on the basis of creating high-precision information models of structural systems.
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Hincapie-Castillo, Juan M., Benjamin Staley, Carl Henriksen, Arwa Saidi, Gloria Pflugfelder Lipori, and Almut G. Winterstein. "Development of a predictive model for drug-associated QT prolongation in the inpatient setting using electronic health record data." American Journal of Health-System Pharmacy 76, no. 14 (2019): 1059–70. http://dx.doi.org/10.1093/ajhp/zxz100.
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Abstract Purpose We aimed to construct a dynamic model for predicting severe QT interval prolongation in hospitalized patients using inpatient electronic health record (EHR) data. Methods A retrospective cohort consisting of all adults admitted to 2 large hospitals from January 2012 through October 2013 was established. Thirty-five risk factors for severe QT prolongation (defined as a Bazett’s formula—corrected QT interval [QTc] of ≥500 msec or a QTc increase of ≥60 msec from baseline) were operationalized for automated EHR retrieval; upon univariate analyses, 26 factors were retained in models for predicting the 24-hour risk of QT events on hospital day 1 (the Day 1 model) and on hospital days 2–5 (the Days 2–5 model). Results A total of 1,672 QT prolongation events occurred over 165,847 days of risk exposure during the study period. C statistics were 0.828 for the Day 1 model and 0.813 for the Days 2–5 model. Patients in the upper 50th percentile of calculated risk scores experienced 755 of 799 QT events (94%) allocated in the Day 1 model and 804 of 873 QT events (92%) allocated in the Days 2–5 model. Among patients in the 90th percentile, the Day 1 and Days 2–5 models captured 351 of 799 (44%) and 362 of 873 (41%) QT events, respectively. Conclusion The risk models derived from EHR data for all admitted patients had good predictive validity. All risk factors were operationalized from discrete EHR fields to allow full automation for real-time identification of high-risk patients. Further research to test the models in other health systems and evaluate their effectiveness on outcomes and patient care in clinical practice is recommended.
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Humairani, Rindhira, Dewi Maritalia, Zara Yuniza, and Sonny M. Ikhsan. "Pendampingan Penerapan GMP Pada Pengolahan Terasi Tutok Di Desa Kuala Pusing Kapal." Lumbung Inovasi: Jurnal Pengabdian kepada Masyarakat 4, no. 1 (2021): 1. http://dx.doi.org/10.36312/linov.v4i1.437.
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Tujuan pengabdian pada masyarakat ini adalah untuk melakukan pendampingan penerapan Good Manufacturing Practice (GMP) pada mitra sebagai salah satu syarat dalam memperoleh sertifikat P-IRT dan legalitas produk lainnya. Mitra kegiatan pengabdian adalah masyarakat pengolah dan produksi terasi tutok di Desa Kuala Pusong Kapal Kecamatan Seruway Kabupaten Aceh Tamiang berjumlah 40 orang. Metode yang digunakan dalam kegiatan pengabdian masyarakat ini adalah pendampingan penerapan GMP dalam proses pengolahan dan produksi terasi tutok, dengan bentuk kegiatan yang dilakukan antara lain : 1) Peningkatan kualitas SDM, 2) Pemisahan ruang produksi dan ruang penyimpanan, 3) Pembuatan rak pengering yang terstandarisasi, 4) Penggunaan Alat Pelindung Diri, 5) Pengadaan wadah fermentasi yang sesuai standar, dan 6) Pengadaan mesin penggiling/penghancur. Hasil kegiatan adalah adanya peningkatan pengetahuan dan pemahaman tentang proses produksi terasi tutok yang terstandar, selain itu pasilitas produksi tersi tutok yang terstandar dapat diadakan dengan kerjasama antara tim pengabdian dan swadaya mitra. Kegiatan pendampingan masih perlu dilakukan secara kontinu sehingga mitra benar-benar dapat memproduksi tersi tutok secara mandiri.Assistance for the Implementation of GMP in Tutok Shrimp Processing in Kuala Pusing Kapal VillageAbstractThe purpose of this community service is to provide assistance to the implementation of Good Manufacturing Practice (GMP) to partners as one of the requirements for obtaining a P-IRT certificate and other product legality. The community service partners consist of 40 people who process and produce shrimp paste in Kuala Pusong Kapal Village, Seruway District, Aceh Tamiang Regency. The method used in this community service activity is assistance in implementing GMP in the processing and production of terasi tutok, with the following activities: 1) Improving the quality of human resources, 2) Separation of production space and storage space, 3) Making standardized drying racks ,4) Use of Personal Protective Equipment, 5) Procurement of fermentation containers in accordance with standards, and 6) Procurement of grinding / crushing machines. The result of the activity is an increase in knowledge and understanding of the standardized tutu terasi production process, besides that standardized terasi tutu production facilities can be held in collaboration between the community service team and partner self-help. Assistance activities still need to be carried out continuously so that partners can actually produce teri tutok independently.
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Ponda, Henri, Nur Fadilah Fatma, and Ade Yusuf. "PENERAPAN HACCP (HAZARD ANALYSIS AND CRITICAL CONTROL POINT) PADA PROSES PRODUKSI SUKLAT MOCACHINO DAN CHOCO GRANULE DI PT. MAYORA INDAH TBK." Heuristic 17, no. 1 (2020): 1–10. http://dx.doi.org/10.30996/he.v17i1.3565.
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Soklat Mocachino dan Choco Granule merupakan salah satu jenis produk pangan olahan, dimana produk pangan selalu dituntut agar aman dan layak dikonsumsi. Dikatakan aman produk pangan olahan tersebut tidak mengandung atau bebas dari bahaya fisik, kimia dan biologi. Untuk itu sangat penting bagi produsen agar selalu memastikan semua tahapan proses produksi yang terlibat didalamnya harus dijaga dengan cara pengolahan yang baik (good manufacturing practice). Dengan cara tersebut seluruh peluang bahaya yang ada dapat teridentifikasi sehingga dapat dilakukan suatu tindakan pengendalian yang spesifik agar bahaya dapat berkurang sampai batas yang dapat diterima. Metode yang digunakan dalam penelitian ini dalam rangka mengurangi bahaya pada produk olahan pangan yaitu HACCP (hazard analysis and critical control point). Berdasarkan hasil analisis bahaya menunjukkan dari 15 tahapan proses produksi yang ada, dimana 5 proses diantaranya merupakan CCP (critical control point) yaitu penimbangan, vacuum belt drying, air blowing transfer, vibroseparator, dan pengemasan. Sedangkan 10 tahapan proses produksi lainnya merupakan OPRP (Operational Pre-Requisite Program).
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Kelutur, Faruk Jayanto, and Holis Abdul Holik. "Use of 99m Tc in The Field of Radiofarmation: A Review." Biomedical Journal of Indonesia 7, no. 1 (2021): 1–10. http://dx.doi.org/10.32539/bji.v7i1.241.
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A B S T R A C TTechnetium-99m ( 99m Tc) has been applied in nuclear medicine as a radiopharmacyfor both diagnosis and therapy. 99m Tc is obtained from a 99 Mo/ 99m Tc (half-life 66 h)generator in the form of sodium pertechnetate (Na[ 99m TcO 4 ]) by decaying to 99 Tc for 6hours and emitting gamma energy rays (Eɤ = 140 keV). This radionuclide has anelectron configuration of 4d 5 5s 2 , which will form complexes with different ligandsand have oxidation rates from +1 to +7. The coordinated complex of technetium-99mhas been utilized in nuclear medicine in tissues and organs (thyroid, red and whiteblood cells, kidneys, brain, myocardial, and bone). The resulting kit production musthave based on Good Manufacturing Practice, which consists of batch planning,washing, sterilization of glassware and stopper, starting material, preparation oflarge quantities of the solution, sterile filtration, dispensing, crimping, a summary ofprocess control, quarantine, packaging and leaving the production premises.
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Bari, Elia, Sara Perteghella, Dario Di Silvestre, et al. "Pilot Production of Mesenchymal Stem/Stromal Freeze-Dried Secretome for Cell-Free Regenerative Nanomedicine: A Validated GMP-Compliant Process." Cells 7, no. 11 (2018): 190. http://dx.doi.org/10.3390/cells7110190.
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In this paper, a pilot production process for mesenchymal stem/stromal freeze-dried secretome was performed in a validated good manufacturing practice (GMP)-compliant cell factory. Secretome was purified from culture supernatants by ultrafiltration, added to cryoprotectant, lyophilized and characterized. We obtained a freeze-dried, “ready-off-the-shelf” and free soluble powder containing extracellular vesicles and proteins. In the freeze-dried product, a not-aggregated population of extracellular vesicles was detected by nanoparticle tracking analysis; Fourier transform infrared spectra showed the simultaneous presence of protein and lipids, while differential scanning calorimetry demonstrated that lyophilization process successfully occurred. A proteomic characterization allowed the identification of proteins involved in immune response, response to stress, cytoskeleton and metabolism. Moreover, the product was not cytotoxic up to concentrations of 25 mg/mL (on human fibroblasts, chondrocytes and nucleus pulposus cells by MTT assay) and was blood compatible up to 150 mg/mL. Finally, at concentrations between 5 and 50 mg/mL, freeze-dried secretome showed to in vitro counteract the oxidative stress damage induced by H2O2 on nucleus pulposus cells by MTT assay.
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Ansari, Sabbir, and Tasneem Fatma. "Characterization of Nostoc muscorum NCCU-442 Derived Poly-3- hydroxybutyrate (PHB) and Polyethylene Glycol (PEG) Blends." Natural Products Journal 10, no. 3 (2020): 200–207. http://dx.doi.org/10.2174/2210315508666180810145127.
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Background: Poly-3-hydroxybutyrate (PHB) has attracted much consideration as biodegradable biocompatible polymer. This thermoplastic polymer has comparable material properties to polypropylene. Materials with more valuable properties may result from blending, a common practice in polymer science. Objective: In this paper, blends of PHB (extracted from cyanobacterium Nostoc muscorum NCCU- 442 with polyethylene glycol (PEG) were investigated for their thermal, tensile, hydrophilic and biodegradation properties. Methods: Blends were prepared in different proportions of PHB/PEG viz. 100/0, 98/2, 95/5, 90/10, 80/20, and 70/30 (wt %) using solvent casting technique. Morphological properties were investigated by using Scanning Electron Microscopy (SEM). Differential scanning calorimetry and thermogravimetric analysis were done for thermal properties determination whereas the mechanical and hydrophilic properties of the blends were studied by means of an automated material testing system and contact angle analyser respectively. Biodegradability potential of the blended films was tested as percent weight loss by mixed microbial culture within 60 days. Results: The blends showed good misciblity between PEG and PHB, however increasing concentrations of plasticizer caused morphological alteration as evidenced by SEM micrographs. PEG addition (10 % and above) showed significant alternations in the thermal properties of the blends. Increase in the PEG content increased the elongation at break ratio i.e enhanced the required plasticity of PHB. Rate of microbial facilitated degradation of the blends was greater with increasing PEG concentrations. Conclusion: Blending with PEG increased the crucial polymeric properties of cyanobacterial PHB.
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Ford, Elizabeth, Joanne Sheppard, Seb Oliver, Philip Rooney, Sube Banerjee, and Jackie A. Cassell. "Automated detection of patients with dementia whose symptoms have been identified in primary care but have no formal diagnosis: a retrospective case–control study using electronic primary care records." BMJ Open 11, no. 1 (2021): e039248. http://dx.doi.org/10.1136/bmjopen-2020-039248.
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ObjectivesUK statistics suggest only two-thirds of patients with dementia get a diagnosis recorded in primary care. General practitioners (GPs) report barriers to formally diagnosing dementia, so some patients may be known by GPs to have dementia but may be missing a diagnosis in their patient record. We aimed to produce a method to identify these ‘known but unlabelled’ patients with dementia using data from primary care patient records.DesignRetrospective case–control study using routinely collected primary care patient records from Clinical Practice Research Datalink.SettingUK general practice.ParticipantsEnglish patients aged >65 years, with a coded diagnosis of dementia recorded in 2000–2012 (cases), matched 1:1 with patients with no diagnosis code for dementia (controls).InterventionsEight coded and nine keyword concepts indicating symptoms, screening tests, referrals and care for dementia recorded in the 5 years before diagnosis. We trialled machine learning classifiers to discriminate between cases and controls (logistic regression, naïve Bayes, random forest).Primary and secondary outcomesThe outcome variable was dementia diagnosis code; the accuracy of classifiers was assessed using area under the receiver operating characteristic curve (AUC); the order of features contributing to discrimination was examined.Results93 426 patients were included; the median age was 83 years (64.8% women). Three classifiers achieved high discrimination and performed very similarly. AUCs were 0.87–0.90 with coded variables, rising to 0.90–0.94 with keywords added. Feature prioritisation was different for each classifier; commonly prioritised features were Alzheimer’s prescription, dementia annual review, memory loss and dementia keywords.ConclusionsIt is possible to detect patients with dementia who are known to GPs but unlabelled with a diagnostic code, with a high degree of accuracy in electronic primary care record data. Using keywords from clinic notes and letters improves accuracy compared with coded data alone. This approach could improve identification of dementia cases for record-keeping, service planning and delivery of good quality care.
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Mielke, Stephan, Raquel Nunes, Katayoun Rezvani, et al. "A clinical-scale selective allodepletion approach for the treatment of HLA-mismatched and matched donor-recipient pairs using expanded T lymphocytes as antigen-presenting cells and a TH9402-based photodepletion technique." Blood 111, no. 8 (2008): 4392–402. http://dx.doi.org/10.1182/blood-2007-08-104471.
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Abstract Selective allodepletion is a strategy to eliminate host-reactive donor T cells from hematopoietic stem cell allografts to prevent graft-versus-host disease while conserving useful donor immune functions. To overcome fluctuations in activation-based surface marker expression and achieve a more consistent and effective allodepletion, we investigated a photodepletion process targeting activation-based changes in p-glycoprotein that result in an altered efflux of the photosensitizer TH9402. Expanded lymphocytes, generated using anti-CD3 and IL-2, were cocultured with responder cells from HLA-matched or -mismatched donors. Optimal results were achieved when cocultured cells were incubated with 7.5 μM TH9402, followed by dye extrusion and exposure to 5 Joule/cm2 light energy at 5 × 106 cells/mL. In mismatched stimulator-responder pairs, the median reduction of alloreactivity was 474-fold (range, 43-fold to 864-fold) compared with the unmanipulated responder. Third-party responses were maintained with a median 1.4-fold (range, 0.9-fold to 3.3-fold) reduction. In matched pairs, alloreactive helper T-lymphocyte precursors were reduced to lower than 1:100 000, while third-party responses remained higher than 1:10 000. This establishes a clinical-scale process capable of highly efficient, reproducible, selective removal of alloreactive lymphocytes from lymphocyte transplant products performed under current Good Manufacturing Practice. This procedure is currently being investigated in a clinical trial of allotransplantation.
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Mulvanny, Alex, Natalie Jackson, Caroline Pattwell, Sophie Wolosianka, Thomas Southworth, and Dave Singh. "The dose response of inhaled LPS challenge in healthy subjects." European Journal of Inflammation 16 (January 1, 2018): 205873921878482. http://dx.doi.org/10.1177/2058739218784820.
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Lipopolysaccharide (LPS) inhalation causes neutrophilic airway inflammation. We used LPS produced to Good Manufacturing Practice (GMP) standards to characterise the dose response. A total of 15 healthy non-smoking subjects inhaled 5-, 15- and 50-µg LPS. Whole blood cell counts and serum C-reactive protein (CRP) were measured at baseline and up to 24 h post challenge. Sputum was induced at baseline and 6 h post challenge for cell counts and quantification of myeloperoxidase (MPO), interleukin (IL)-1β, IL-6, IL-8 and tumour necrosis factor α (TNF-α) in supernatants. LPS inhalation was well tolerated. Blood neutrophil counts increased at 6 h post LPS with all doses. Serum CRP significantly increased with 15- and 50-µg LPS. All LPS doses significantly increased sputum neutrophil percentage ( P < 0.001). IL-1β, IL-6 and TNF-α were significantly increased in sputum supernatant following challenge with 50-µg LPS, there was no change in MPO or IL-8. The 50-µg LPS was well tolerated and produced a robust inflammatory response. This study supports the use of 50-µg GMP-grade LPS as a suitable challenge agent in clinical trials.
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Tanosaki, Ryuji, Yoshiki Okuyama, Tohru Iseki, et al. "Enumeration of Peripheral Blood Hematopoietic Stem Cells Using Automated Hematology Analyzer, Sysmex-XN: Final Resutls of Multicenter Prospective Study." Blood 126, no. 23 (2015): 4304. http://dx.doi.org/10.1182/blood.v126.23.4304.4304.
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Abstract We conducted a multicenter study to evaluate a new enumeration method of hematopoietic progenitor cells (HPC) using an automated hematology analyzer, the XN-series model (Sysmex Corporation, Japan). This method appeared to be very promising in a pilot study in a single institution [Tanosaki R, et al. Int J Lab Hematol 2013]. We herein discuss the final results of our study. PB or PBSC samples were taken from G-CSF- and/or chemo-mobilized subjects. The samples were divided into two tubes, one for an in-house assay where HPC were counted in each institution and one was shipped to a central laboratory (SRL, Inc., Japan) where the CD34+ cell count was examined. Firstly, we examined the frequency of invalid data. Secondly, the correlation between HPC and CD34+ cells was investigated. Thirdly, cut-off HPC values were determined to predict certain CD34+ cell counts, i.e. 20 cells/µL for PB and 1,000 cells/µL for PBSC. Finally, for the clinical application, we estimated values which predicted more than certain CD34+ cell counts with 95% probability by constructing a two-dimensional normal distribution model. This study was approved by the IRB of each institution, and informed consent was obtained from each participant before apheresis. One hundred and nine subjects (46 healthy donors and 63 patients undergoing PBSCT) were registered in 5 institutions, and 954 HPC measurements from 614 samples were performed. Thirteen (4.4%) HPC values in 297 PBSC assays were estimated to be invalid, which was identified by an asterisk automatically applied to the corresponding result. Next, the data of the first assay from each sample where both the HPC and the central laboratory-based CD34+ count were available were extracted, and 470 HPC-CD34+ pairs from 102 subjects (43 healthy donors and 59 patients) were used for further analyses. The median age was 50.5 years (range, 3-78), 60 males and 42 females, and diagnoses were malignant lymphoma 28 patients, multiple myeloma 27, and others. It was revealed that there was one mismatched result in the PBSC samples (arrow in Fig 1B; HPC 35,768/µL, CD34+ 399/µL). When this value was removed, strong correlations between the HPC and CD34+ cell counts were observed in both the PB (r=0.94) and PBSC (r=0.97) samples (Fig 1). Strong correlations were observed also at each institution. The HPC cut-off values to distinguish CD34+ cell counts below or above 20/µL in PB and 1,000/µL in PBSC samples were determined to be 25 (AUC 0.931, Youden Index 0.713) and 921 (AUC 0.946, Youden Index 0.778), respectively, by a ROC analysis (Fig 2). Finally, HPC of 56/µL was determined to be the optimal value for predicting more than 20/µL of CD34+ cells in the PB samples with 95% probability. This study confirmed that there was a strong correlation between the HPC and CD34+ cell count in a larger number of patients with different diagnosis at different institutions. For the PBSC collection, HPC ≥ 25/µL suggested an appropriate timing, and HPC 56/µL indicated a more secure threshold. HPC may also be a useful marker to rapidly estimate the quantity of CD34+ cells in the apheresis product. In cases where the HPC value is invalid, this may be overcome by serially evaluating HPC in the clinical course. In conclusion, HPC may be a good surrogate or an alternative for the CD34+ cell count. Prospective studies are warranted to verify the usefulness of HPC in clinical practice. Disclosures No relevant conflicts of interest to declare.
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Giulivi, Antonio, Mike Halpenny, Paul Birch, Lyn Yang, and Lisa Martin. "Generation of Dendritic Cells in a Closed System Using GMP Guidelines." Blood 104, no. 11 (2004): 2878. http://dx.doi.org/10.1182/blood.v104.11.2878.2878.
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Abstract Objective: The application of a dendritic cell (DC) based immunotherapy requires the ability to consistently produce a clinically acceptable product using Good Manufacturing Practice (GMP). We describe our experience using the Nexell SteriCell container to generate monocyte derived DC in a closed system using GMP guidelines. Design/Materials and Methods: Leukapheresis product was used as source material to first isolate monocytes by adherence to culture bag and then generate DC from monocytes using a serum free media containing GM-CSF and IL-4 and culturing for 7 days at 37°C /5% CO2. DC generation was characterized by phenotyping cultured cells for decreased expression of CD14 and increased appearance of CD80, CD86 and DR. In addition to phenotyping, cultures were tested pre and post culturing for viability and microbial contamination. Results: Cultured cells expressed a decreased expression of CD14 (mean % decrease 58.8 /range 11.2–94.9) and increased expression of CD 80/86 (mean fold increase 23.6X /range 5.7 – 36.2), and DR (mean fold increase 9.3X /range 3.2 – 16). All microbial cultures were negative and viability ranged from 54% to 90% post incubation. Conclusions: The Canadian Blood Services cell processing laboratory is a FACT (Foundation for the Accreditation of Cellular Therapy) accredited facility following GMP guidelines. The results obtained from our study demonstrate a system easily adaptable to larger scale production of DC for possible future immunotherapy clinical application.
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Montalvão, Silmara Lima, Sandra Martins Silva Soares, Marina P. Colella, Joyce M. Annichino-Bizzacchi, Samuel de Souza Medina та Margareth C. Ozelo. "Impact of Two Immobilized GPIbα Assays in the Diagnosis of Von Willebrand Disease". Blood 124, № 21 (2014): 1524. http://dx.doi.org/10.1182/blood.v124.21.1524.1524.
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Abstract The diagnosis of von Willebrand Disease (VWD) remains a challenge of daily hematology practice. Ristocetin cofactor activity (VWF:RCo) is an important parameter for the diagnosis of VWD and is also essential for its management. However, reproducibility of the available tests for VWF:RCo is still a major issue, as evidenced by coefficient of variations (CV) as high as 30%, 45% and 27% in the ECAT, NEQAS and PALQ external quality assessment program. Classical methods to measure VWF:RCo include light-transmission platelet agregometry (LPA) and visual agglutination with formaldehyde fixed human platelet (VA), and more recently, VWF activity based on automated latex immunoassay (LIA). The glycoprotein (GP) Ibα is the main receptor for von Willebrand factor (VWF) in the platelet membrane. Currently, two automated methods with immobilized GPIbα have been developed to improve the sensitivity and specificity of VWF:RCo. One of them is performed with ristocetin while the other one uses a mutant GPIbα with gain of function and does not require ristocetin. This study aims to compare the two assays using immobilized GPIbα with other four assays for VWF functional determination, in patients with confirmed and under investigation for VWD. We evaluated six different VWF functional assays: VWF:RCo LPA (Chrono-Log); VA (Siemens); VA in house (with ristocetin from Chrono-Log); automated-LIA (Hemosil); in comparison to two assays using immobilized GPIbα with or without ristocetin, the GPIbα-ristocetin (Hemosil), and GPIbα-mutant (Siemens Innovance). Reference ranges for each method were established in 20 healthy adults. Plasma samples collected at the same time from 40 individuals were used in this comparative study, with 25 type 1 VWD, 2 type 3 VWD, and 13 under investigation. Diagnosis of VWD was based on bleeding history (evaluated by MCMDM-1VWD Bleeding Score), historical levels of VWF antigen (VWF:Ag) by ELISA, and VWF:RCo (assayed by LTA or VA) obtained from medical records. Statistical analysis were performed based on linear regression (Spearman correlation), agreement test (Altman Bland), and chi-square test using Prism 6.0. When all 40 patients were evaluated for both methods, GPIbα-ristocetin and GPIbα-mutant, we observed a good coefficient of correlation (r = 0.8954; p<0.0001). However, when 7 type 1 VWD patients, and 1 under investigation case were evaluated for the six methods, the two using immobilized GPIbα showed lower median (16.78 ± 4.62 with GPIbα-ristocetin, and 16.28 ± 4.29 with GPIbα-mutant), when compared with the other four assays (LTA: 22.38 ± 5.5; VA in house: 21.45 ± 4.87; VA Siemens: 22.65 ± 4.9; and LIA: 24.19 ± 9.0). In this group, when the bleeding score (BS) were ≥ 5, the VWF functional results were lower than 25 IU/dL, using all six methods (figure). Among 13 individuals under VWD investigation, GPIbα-ristocetin and GPIbα-mutant showed good agreement with the LTA/VA results and clinical history, and we could concluded that 4 have VWD, and for 4 individuals VWD was excluded. However, 2 individuals with no history of bleeding presented abnormal results for GPIbα-ristocetin and GPIbα-mutant, showing probably false positive results. One patient with no bleeding history, and abnormal LTA/VA results had normal GPIbα-ristocetin and GPIbα-mutant results, demonstrating poor reproducibility and precisian of the classical methods. On the other hand, two patient with BS 6, the diagnosis of VWD was demonstrating only by immobilized GPIbα methods. The VWF:RCo is a cumbersome assay and can be affected by polymorphisms present in the ristocetin binding site of VWF. Recently, new technologies have been developed to improve the VWF functional evaluation. It is consensus that methodologies using platelets are more accurate than other methods. Therefore, immobilized GPIbα has the objective to improve the sensitivity and specificity. Besides good results of concordance between immobilized GPIbα in the group of VWD patients and for 62% individual under investigation, we also observed false positive results related with these methods. The presence or absence of ristocetin on the immobilized GPIbα setting appear not engender different results in this study. In general, this new technologies present better precision compared to VA and LTA. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.
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Downie, Aron Simon, Mark Hancock, Christina Abdel Shaheed, et al. "An Electronic Clinical Decision Support System for the Management of Low Back Pain in Community Pharmacy: Development and Mixed Methods Feasibility Study." JMIR Medical Informatics 8, no. 5 (2020): e17203. http://dx.doi.org/10.2196/17203.
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Background People with low back pain (LBP) in the community often do not receive evidence-based advice and management. Community pharmacists can play an important role in supporting people with LBP as pharmacists are easily accessible to provide first-line care. However, previous research suggests that pharmacists may not consistently deliver advice that is concordant with guideline recommendations and may demonstrate difficulty determining which patients require prompt medical review. A clinical decision support system (CDSS) may enhance first-line care of LBP, but none exists to support the community pharmacist–client consultation. Objective This study aimed to develop a CDSS to guide first-line care of LBP in the community pharmacy setting and to evaluate the pharmacist-reported usability and acceptance of the prototype system. Methods A cross-platform Web app for the Apple iPad was developed in conjunction with academic and clinical experts using an iterative user-centered design process during interface design, clinical reasoning, program development, and evaluation. The CDSS was evaluated via one-to-one user-testing with 5 community pharmacists (5 case vignettes each). Data were collected via video recording, screen capture, survey instrument (system usability scale), and direct observation. Results Pharmacists’ agreement with CDSS-generated self-care recommendations was 90% (18/20), with medicines recommendations was 100% (25/25), and with referral advice was 88% (22/25; total 70 recommendations). Pharmacists expressed uncertainty when screening for serious pathology in 40% (10/25) of cases. Pharmacists requested more direction from the CDSS in relation to automated prompts for user input and page navigation. Overall system usability was rated as excellent (mean score 92/100, SD 6.5; 90th percentile compared with similar systems), with acceptance rated as good to excellent. Conclusions A novel CDSS (high-fidelity prototype) to enhance pharmacist care of LBP was developed, underpinned by clinical practice guidelines and informed by a multidisciplinary team of experts. User-testing revealed a high level of usability and acceptance of the prototype system, with suggestions to improve interface prompts and information delivery. The small study sample limits the generalizability of the findings but offers important insights to inform the next stage of system development.
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You, Hong, Bailey Ireland, Michael Moeszinger, et al. "Determination of Select Nonvolatile Ginger Constituents in Dietary Ingredients and Finished Dosage Forms, First Action 2018.04." Journal of AOAC INTERNATIONAL 103, no. 1 (2020): 124–31. http://dx.doi.org/10.5740/jaoacint.19-0004.
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Abstract A consensus industrial reference was necessary to be established for meeting the U.S. Food and Drug Administration’s current Good Manufacturing Practice Compliance for the manufacture and quality control of dietary ingredients and supplements that contain ginger rhizome, dry extract, and/or purified nonvolatile ginger constituents. An analytical method has been developed, validated, and previously published for identifying and quantifying 6-,8- and 10-gingerols, 6-, 8- and 10-shogaols, 6-paradol, and zingerone. HPLC with UV-Vis detector was used for the determination of nonvolatile ginger constituents by following AOAC Guidelines for Single-Laboratory Validation. Sample was accurately weighed and diluted with acidified water and methanol mixture. The sample solution was then sonicated and filtered through a PTFE filter and analyzed under a linear gradient scheme instrument condition. A reverse-phase superficially porous particle C18 column and an absorption wavelength of 230 nm were used for analyte separation and determination. The method was demonstrated to be selective, linear (R2 &gt; 0.999), specific, accurate (91.1–103.2% spike recovery rate), and precise (RSDr &lt; 5%, RSDR &lt; 8%) and therefore met all AOAC Standard Method Performance Requirements (2017.012) criteria. With a relatively short run time (12 min) and optimized extraction solvent system, the method has been validated to simultaneously determine nonvolatile ginger constituents in a variety of dietary ingredients and dietary supplements matrices including dry extract, powder, tablet, capsule, liquid capsule, softgel capsule, and oleoresin.
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Kastaman, Roni, and Ahmad Thoriq. "Prioritas Strategi Pengembangan Agroindustri Manggis di Kabupaten Tasikmalaya, Jawa Barat." Agrikultura 31, no. 3 (2021): 228. http://dx.doi.org/10.24198/agrikultura.v31i3.30525.
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Manggis merupakan tanaman buah yang termasuk ke dalam pangan fungsional karena memiliki banyak manfaat bagi kesehatan. Sebagian besar buah manggis dijual dalam bentuk buah segar, padahal buah manggis dapat diolah menjadi beberapa produk sehingga dapat meningkatkan nilai tambah buah manggis. Penelitian ini bertujuan menentukan lokasi potensial, prioritas dan arah pengembangan agroindustri manggis di Kabupaten Tasikmalaya. Penentuan lokasi potensial dilakukan menggunakan metode Location Quotient (LQ) and Differential Shift (DS), penentuan prioritas produk agroindustri manggis dilakukan menggunakan metode perbandingan ekponensial, strategi pengembangan agroindustri manggis dilakukan menggunakan analisis SWOT (Strengths, Weaknesses, Opportunities, and Threats) dan pemilihan prioritas strategi pengembangan agroindustri manggis dilakukan menggunakan Analytical Network Process (ANP). Hasil analisis LQ dan DS menunjukkan bahwa lokasi potensial pengembangan agroindustri manggis terdapat pada empat Kecamatan di Kabupaten Tasikmalaya yaitu Kecamatan Sodonghilir, Tanjungjaya, Sukaraja, dan Kecamatan Jatiwaras. Prioritas pengembangan produk agroindustri manggis berdasarkan analisis metode perbandingan ekponensial secara berurutan adalah ekstrak kulit manggis (9,63), sari buah/ jus manggis (9,56), sirup buah manggis (9,53), buah kaleng manggis (9,51), puree manggis (9,50), es krim kulis manggis (9,48), dodol biji manggis (9,47), dan tepung kulit manggis (9,45). Berdasarkan analisis SWOT dan ANP diperoleh prioritas strategi pengembangan agroindustri manggis bagi petani, yakni : 1) branding dan promosi produk, 2) Peningkatan kualitas produk melalui penerapan Good Manufacturing Practice (GMP) dan Cleaner Production, 3) Pengembangan dan inovasi produk, 4) Peningkatan kualitas sumber daya manusia, 5) Peningkatan kesejahteraan petani, 6) Bibit unggul yang mampu adaptif terhadap lingkungan, 7) Peningkatan harga jual buah manggis.
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Samarasinghe, Sujith, Christoph Mancao, Martin Pule, et al. "Functional characterization of alloreactive T cells identifies CD25 and CD71 as optimal targets for a clinically applicable allodepletion strategy." Blood 115, no. 2 (2010): 396–407. http://dx.doi.org/10.1182/blood-2009-08-235895.
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AbstractImmunotherapy with allodepleted donor T cells (ADTs) improves immunity after T cell–depleted stem cell transplantation, but infection/relapse remain problematic. To refine this approach, we characterized the expression of surface markers/cytokines on proliferating alloreactive T cells (ATs). CD25 was expressed on 83% of carboxyfluorescein diacetate succinimidyl esterdim ATs, confirming this as an excellent target for allodepletion. Seventy percent of CD25− ATs expressed CD71 (transferrin receptor), identifying this as a novel marker to target ATs persisting after CD25 depletion. Comparison of residual alloreactivity after combined CD25/71 versus CD25 immunomagnetic depletion showed enhanced depletion of alloreactivity to host with CD25/71 depletion in both secondary (2°) mixed lymphocyte reactions (P < .01) and interferon-γ enzyme-linked immunospot assays (P < .05) with no effect on third-party responses. In pentamer/interferon-γ enzyme-linked immunospot assays, antiviral responses to cytomegalovirus, Epstein-Barr virus, and adenovirus were preserved after CD25/71 allodepletion. CD25/71 ADTs can be redirected to recognize leukemic targets through lentiviral transfer of a chimeric anti-CD19ζ T-cell receptor. Finally, we have established conditions for clinically applicable CD25/71 allodepletion under European Union Good Manufacturing Practice conditions, resulting in highly effective, reproducible, and selective depletion of ATs (median residual alloreactivity to host in 2° mixed lymphocyte reaction of 0.39% vs third-party response of 62%, n = 5). This strategy enables further clinical studies of adoptive immunotherapy with larger doses of ADTs to enhance immune reconstitution after T cell-depleted stem cell transplantation.
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DAHMS, S., and G. HILDEBRANDT. "Some Remarks on the Design of Three-Class Sampling Plans." Journal of Food Protection 61, no. 6 (1998): 757–61. http://dx.doi.org/10.4315/0362-028x-61.6.757.
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Among the variety of sampling plans for the evaluation of bacterial counts the attributive three-class sampling plan has widely gained acceptance because of its simple application and its robust functionality. However, the performance characteristics of three-class sampling plans depend on lot heterogeneity and the distance between the microbiological limits m and M, which are the maximum level of target organisms under conditions of good manufacturing practice (GMP) and the level of target organisms that is considered as unacceptable or defective. The probability of lot rejection due to a single sample result above M increases with increasing lot heterogeneity and/or with decreasing distance between these limits. Especially for investigations on nonpathogenic microorganisms it is questionable whether a lot still meeting GMP conditions should be rejected solely because a single sample result lies above M. Taking the often used three-class sampling plan (n = 5; cm = 2, cM = 0) as an example, it is demonstrated how insight into the relationship between sample variability and an appropriate distance between m and M can be gained. These calculations are based on the assumptions that logarithmically transformed bacterial counts follow a normal distribution and that an indifference lot with a contamination level at m is to be evaluated. For this kind of lot the probability of acceptance or rejection is equally 0.5 according to the two-class sampling plan. Introducing a limit for the additional risk of rejection of an indifference lot with acceptable heterogeneity when the three-class sampling plan is applied, a criterion for choosing the distance between m and M is developed.
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Faraghat, Shabnam A., Kai F. Hoettges, Max K. Steinbach, et al. "High-throughput, low-loss, low-cost, and label-free cell separation using electrophysiology-activated cell enrichment." Proceedings of the National Academy of Sciences 114, no. 18 (2017): 4591–96. http://dx.doi.org/10.1073/pnas.1700773114.
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Currently, cell separation occurs almost exclusively by density gradient methods and by fluorescence- and magnetic-activated cell sorting (FACS/MACS). These variously suffer from lack of specificity, high cell loss, use of labels, and high capital/operating cost. We present a dielectrophoresis (DEP)-based cell-separation method, using 3D electrodes on a low-cost disposable chip; one cell type is allowed to pass through the chip whereas the other is retained and subsequently recovered. The method advances usability and throughput of DEP separation by orders of magnitude in throughput, efficiency, purity, recovery (cells arriving in the correct output fraction), cell losses (those which are unaccounted for at the end of the separation), and cost. The system was evaluated using three example separations: live and dead yeast; human cancer cells/red blood cells; and rodent fibroblasts/red blood cells. A single-pass protocol can enrich cells with cell recovery of up to 91.3% at over 300,000 cells per second with >3% cell loss. A two-pass protocol can process 300,000,000 cells in under 30 min, with cell recovery of up to 96.4% and cell losses below 5%, an effective processing rate >160,000 cells per second. A three-step protocol is shown to be effective for removal of 99.1% of RBCs spiked with 1% cancer cells while maintaining a processing rate of ∼170,000 cells per second. Furthermore, the self-contained and low-cost nature of the separator device means that it has potential application in low-contamination applications such as cell therapies, where good manufacturing practice compatibility is of paramount importance.
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Osypenko, Volodymyr, Borys Zlotenko, Tetiana Kulik, et al. "Improved algorithm for matched-pairs selection of informative features in the problems of recognition of complex system states." Eastern-European Journal of Enterprise Technologies 2, no. 4 (110) (2021): 48–54. http://dx.doi.org/10.15587/1729-4061.2021.229756.
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The problem of computer diagnostics of complex systems is one of the non-trivial tasks of modern information technology. Such systems are, for example, computer networks, automatic and/or automated control systems for complex technological objects, including related to complex problems of environmental protection, biology, etc. In pattern recognition, one of the major problems is forming subspaces of informative features, which only in the «ensemble» allow diagnosing the states of such systems with a high degree of reliability. An effective approach to solving this problem based on the principles of inductive modeling of complex systems is proposed. The quality criterion for recognizing classes of patterns is formulated, which also makes it possible to evaluate the quality of the constructed ensemble of informative features. As an example, the problem of constructing an ensemble of informative features represented by a binary code based on the data of an experiment to determine the hazard levels of some plant protection products is considered. Real primary data on plant protection products used in practice were applied to recognize the effect of certain characteristics on the so-called integrated «hazard indicator». Comparative numerical estimates of the effectiveness of the proposed approach are given. In this case, there can be a fivefold gain in the amount of computations for a relatively small number of input features equal to 5 compared to the known algorithms of the class considered in the paper. It is shown that, from a practical point of view, the described algorithm has advantages over the known algorithms with brute-force search of feature subspaces in pattern recognition problems.