Academic literature on the topic 'Good Automated Manufacturing Practice 5'
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Journal articles on the topic "Good Automated Manufacturing Practice 5"
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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.
Full textDissertations / Theses on the topic "Good Automated Manufacturing Practice 5"
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Rainho, Inês Margarida Louro. "Validação das Folhas de Cálculo Eletrónicas dos Produtos Acabados e de Estabilidade dos Laboratórios Vitória, S.A." Master's thesis, 2018. http://hdl.handle.net/10362/58225.
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As folhas de cálculo eletrónicas são bastante utilizadas na indústria farmacêutica no processamento e registo de informação, sendo equiparadas aos sistemas computadorizados e consideradas registos eletrónicos quando armazenadas eletronicamente, sendo fundamental que cumpram todas as Boas Práticas de Fabrico relativas a estes dois aspetos e que sejam validadas de modo a assegurar que estas são cumpridas e que as folhas de cálculo eletrónicas estão corretas.
Assim, um dos principais objetivos deste trabalho é a validação das folhas de cálculo eletrónicas dos produtos acabados e de estabilidade utilizadas no Laboratório do Controlo da Qualidade dos Laboratórios Vitória S.A. de acordo com o método da International Society for Pharmaceutical Engineering publicado na Good Automated Manufacturing Practice 5. Para tal, realizou-se uma análise do risco de modo a identificar 57 perigos decorrentes do desenvolvimento e da utilização das mesmas e as respetivas medidas de intervenção. No seguimento da análise do risco, determinou-se que o impacto da utilização das folhas de cálculo eletrónicas é elevado, o que possibilitou, em conjunto com a categorização das mesmas, a selecção da abordagem da validação.
Previamente à validação, todas as folhas de cálculo eletrónicas foram verificadas quanto à existência de erros e foram implementadas as medidas de intervenção que eliminam ou mitigam os perigos. Foram ainda implementados critérios relativos ao desenvolvimento de folhas de cálculo eletrónicas que permitem a sua uniformização e verificação pormenorizada. Foi feita uma comparação entre as folhas de cálculo eletrónicas antes e depois da implementação dos critérios e concluiu-se que alguns nunca eram cumpridos e outros eram irregularmente cumpridos. A implementação desses critérios resultou numa melhoria das folhas de cálculo eletrónicas.
Por fim, foram validadas 15 folhas de cálculo eletrónicas, não sendo, no entanto, possível afirmar que estão devidamente validadas pois os testes relativos às medidas não implementadas não foram realizados.
Books on the topic "Good Automated Manufacturing Practice 5"
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Forum, GAMP. GAMP guide for validation of automated systems. Good automated manufacturing practice: GAMP 4. 4th ed. Society for Pharmaceutical and Medical Device Professionals, 2001.
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Blokdyk, Gerardus. Good Automated Manufacturing Practice a Complete Guide - 2020 Edition. Emereo Pty Limited, 2020.
Find full textBook chapters on the topic "Good Automated Manufacturing Practice 5"
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"Chapter 5." In Good Pharmaceutical Manufacturing Practice. CRC Press, 2004. http://dx.doi.org/10.1201/9780203489116-8.
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"Chapter 2." In Good Pharmaceutical Manufacturing Practice. CRC Press, 2004. http://dx.doi.org/10.1201/9780203489116-5.
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Davis, Alan R., and Colleen Baker. "Production of Clinical Lots of Gene Therapy Vectors Using Good Manufacturing Practice: Experience in a University Setting." In Clinical Trials of Genetic Therapy with Antisense DNA and DNA Vectors. CRC Press, 2020. http://dx.doi.org/10.4324/9781003064657-5.
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Davis, Alan R., and Colleen Baker. "Production of Clinical Lots of Gene Therapy Vectors Using Good Manufacturing Practice: Experience in a University Setting." In Clinical Trials of Genetic Therapy with Antisense DNA and DNA Vectors. CRC Press, 2020. http://dx.doi.org/10.1201/9781003064657-5.
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Davis, Richard J. "Chapter 5 Judge Wolin's interpretations of current good manufacturing practice issues contained in the Court's ruling in the United States v. Barr Laboratories." In Development and Validation of Analytical Methods. Elsevier, 1996. http://dx.doi.org/10.1016/s1464-3456(96)80007-x.
Full textConference papers on the topic "Good Automated Manufacturing Practice 5"
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Brechan, B., S. Sangesland, and S. Dale. "Improved Model for Tubular Burst." In ASME 2019 38th International Conference on Ocean, Offshore and Arctic Engineering. American Society of Mechanical Engineers, 2019. http://dx.doi.org/10.1115/omae2019-95819.
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Abstract Modern casing design can reduce significant amounts of CO2 and considerable cost per well [1]. Collapse design was modernized by ISO/API Technical committee 67, Sub Committee 5, Work Group 2b (ISO/API TC67/SC5/WG2b). Modernization of burst design has so far not had the same focus and only minor changes have been made. A new burst design model has been developed to add to the collapse prediction for a complete environmental and cost effective well design tool. It is based on the theories of Lubinski [2] (1975) and presents designs using “exact von Mises ellipsis” together with the Klever and Stewart ductile rupture model [3]. This paper presents the model developed for burst design and the improvement compared to current industry practice. Inspired by the current most accurate collapse prediction model [4], the modified burst model (prototype) is the first to consider actual wall thickness to predict a more accurate internal yield of OCTG (Oil Country Tubular Goods). Investigations show that the standard 12.5% wall thickness reduction for manufacturing tolerances may be obsolete. ISO 10400 offers physical measurements and statistics of tubular properties. Following the principals by WG2b applied with the Klever & Tamano collapse prediction, there is a set of data to be used for a specific batch of tubulars or they are deducted through large quantum of measurements; ensemble Probability Density Function (PDF). The value proposed as “ensemble PDF” for wall thickness is based on more than 10 000 measurements of tubulars from 11 vendors distributed over Electrical Weld (EW) and quenched and tempered (Q&T) qualities of miscellaneous sizes and grades. The batch specific value proposed is based on more modest numbers of specimens from 4 sources but offers “minimum measured wall thickness” for all the samples. Adding to the confidence of the final design is the automated ductile burst calculation, which is one of the latest contributions to burst modeling in the industry [4] [5] [6]. It is a useful aid for the design engineer to know the potential failure mode and the limit before loss of integrity. However, burst is limited to yield because exceeding this limit may lead to loss of the pipe’s effective diameter and eventually loss of integrity. Therefore, the ductile burst prediction is proposed as a visual aid only.
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Del Prete, A., and G. Papadia. "Sheet Metal Hydroforming Tryout Through Numerical and Experimental Validation." In ASME 2009 International Manufacturing Science and Engineering Conference. ASMEDC, 2009. http://dx.doi.org/10.1115/msec2009-84182.
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Though sheet hydroforming has often been considered a good opportunity for industrial applications related to niche and medium-low volume productions, this technology has not yet found a specific application context as it is for tubes hydroforming (1). Thanks to its extensive application to industrial cases, the latter has defined, through appropriate experimental validations, ‘best practice’ rules for process design (2) and for its tryout (3, 4 and 5). Though not as exploited, sheet hydroforming has many advantages that meet industrial needs very well, such as: formability improvement, good surface quality, higher dimensional accuracy, springback reduction (6). In this paper proper metal forming numerical models and experimental analysis have been developed in order to analyze the feasibility of an industrial test case process design using this non conventional technology. Two different initial blank shapes, two different blank holder load paths (that is made up of twelve sectors) and, finally, two different fluid pressure load paths have been tested. There is clearly a good correlation among numerical and experimental results and also a robust response of the designed mechanical equipment which is able to follow, with a good accuracy, the assigned process characteristics (fluid pressure, blank holder force distribution, etc.). Different process conditions have been numerically and experimentally tested, not reaching, at this stage, the feasibility or, it would be better to say, the ‘hydroformability’ of the product.
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Johansson, Joel. "Automated Manufacturability Analysis of the Draw Bending of Complex Aluminum Profiles." In ASME 2009 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference. ASMEDC, 2009. http://dx.doi.org/10.1115/detc2009-86034.
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Manufacturing companies are required to develop and produce products that meet increased requirements from customers and investors on shortened time spans. One key factor in meeting these requirements is the efficiency of the product development and the production preparation process. Design automation is a powerful tool to increase efficiency in these two processes. The benefits of automating the production preparation process are shortened lead-time, improved product performance, and ultimately decreased cost. Further, automation is beneficial as it increases the ability to adapt products to new product specifications with production preparations done in few or in a single step. During the automation process, knowledge about the production preparation process is collected and stored in the corporation systems, thus allowing full control over the design of production equipments. The contribution of this work is a method for connecting knowledge pieces implemented in auxiliary software applications using an inference engine. The knowledge pieces can control CAD-models and automatically generate, execute, and interpret finite element analyses. The presented method allows the automation of corporation know-how developed by skilled engineers over time. Further, it is possible for the resulting systems to meet criteria for good design automation systems such as low effort of developing, low level of investment, user readable and understandable knowledge, scalability, and flexibility. The method is exemplified by an implementation for analyzing manufacturability of the rotary draw bending of extruded sections of aluminum where the sections are complex. The output from the example system is based on established design practice and heuristic knowledge developed over many years of practical experience, rules analytically derived from fundamental physical laws, and finite element calculations. The system applies knowledge to a given specification that a skilled engineer otherwise would do manually. The method is described along with the example system in this paper.
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Kröger, Georg, Rainer Schnell, and Nicholas D. Humphreys. "Optimised Aerodynamic Design of an OGV With Reduced Blade Count for Low Noise Aircraft Engines." In ASME Turbo Expo 2012: Turbine Technical Conference and Exposition. American Society of Mechanical Engineers, 2012. http://dx.doi.org/10.1115/gt2012-69459.
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In order to meet the ACARE environmental goals further noise reduction from aircraft operation is required relative to that achieved to date. To support this aim the European Commission Seventh Framework Programme promotes the “Optimisation for low Environmental Noise impact AIRcraft (OPENAIR)” programme. Within the OPENAIR programme Rolls-Royce leads the Integrated Propulsion System Design sub platform containing a task to produce multi disciplinary optimized Fan System outlet guide vane (OGV) designs. As a partner in this task, DLR have undertaken an aerodynamic optimized design for a novel OGV concept as the first part within this task. As a starting point, Rolls-Royce specified a high bypass ratio turbo fan engine style and a novel OGV number and space envelope within the engine. Within the EU FP6 VITAL programme a lower number of OGVs compared to current practice was investigated [1] and Rolls-Royce had previously undertaken rig tests of a range of fan / OGV blade ratios and showed potential noise penalties but also benefits, particularly for the higher tone harmonics and broadband noise for very low numbers of OGVs [2]. The advent of multidisciplinary optimization techniques for noise, aerodynamics and mechanical constraints led Rolls-Royce to specify a very low number of OGVs to investigate the benefits and the mitigation of the penalties using these optimization techniques. The multidisciplinary design optimization was planned to be undertaken in two parts. The aim of the first part, to be reported in this paper, was to achieve a good aerodynamic design for the novel OGV concept. Controlling the aerodynamic secondary losses was expected to be a challenge for the novel concept. The second part of the optimisation will also include noise. As part of the initial design optimization study within OPENAIR, DLR present a multi objective aerodynamic design optimization for the novel very low OGV number and space envelope specified. The blade number of the OGV was reduced from 42 to 14. The first design phase covered the two dimensional airfoil section design for the reduced blade count OGV. In order to achieve an enhanced aerodynamic performance with a reduced blade number an automated process chain was used to couple the DLR in house optimiser AutoOpti [3, 4] with the two dimensional flow solver MISES [5]. Three operating points were considered in the aerodynamic design covering a wide range of the compressor operating map. It has been found that the design of a low blade count OGV is feasible by means of good aerodynamic performance. Additionally the aerodynamic losses could be reduced in all operating points further and small flow separation areas on the suction surface closed to the hub and tip endwalls implied a further improvement potential. Therefore, the second design phase was focused on the three dimensional endwall optimisation including a variable flow duct and fillet geometry. An automated process chain was established for this purpose. As a result the flow separation was prevented in all operating points. In the last step of the DLR work a high fidelity URANS simulation of the configuration with the newly designed OGV was conducted to assess its aero-acoustical behavior at this stage of the aerodynamically optimized OGV design and the emitted sound power level downstream the OGV for the optimised low blade number configuration is presented in this work.