Relevant bibliographies by topics / Production clinique grade GMP

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  1. Journal articles
  2. Dissertations / Theses
  3. Book chapters
  4. Conference papers

Academic literature on the topic 'Production clinique grade GMP'

Author: Grafiati
Published: 5 April 2025

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Journal articles on the topic "Production clinique grade GMP"

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Derenne, S., K. Tertrais, A. G. Chartois, F. Auffray, B. Clemenceau, and H. Vie. "Production de MTI de grade clinique par l’EFS Atlantic Bio GMP : transposition d’échelle, validation et production de lymphocytes T cytotoxiques anti-CMV tierce partie." Transfusion Clinique et Biologique 20, no. 3 (2013): 277. http://dx.doi.org/10.1016/j.tracli.2013.04.085.

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Rudiyanto, Heru. "The Study of Good Manufacturing Practices (GMP) and Good Quality Wingko Based on SNI-01-4311-1996." JURNAL KESEHATAN LINGKUNGAN 8, no. 2 (2016): 148. http://dx.doi.org/10.20473/jkl.v8i2.2016.148-157.

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Abstract: Wingko is a special snack from Kecamatan Babat, Kabupaten Lamongan. One of home industries that produce Wingko in Babat City is UD. Bintang Jaya. The making process of Wingko is done traditionally, by using human power. It is really possible for microorganisms to contaminate and affect the quality of Wingko through this process. To raise the quality of food, food controlling is badly needed. Good Manufacturing Practices (GMP) is one of systems that describes the terms that have to be fulfi lled by home industries. The purpose of this research is to identify the production of wingko a
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Lechanteur, Chantal, Alexandra Briquet, Virginie Bettonville, Etienne Baudoux, and Yves Beguin. "MSC Manufacturing for Academic Clinical Trials: From a Clinical-Grade to a Full GMP-Compliant Process." Cells 10, no. 6 (2021): 1320. http://dx.doi.org/10.3390/cells10061320.

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Following European regulation 1394/2007, mesenchymal stromal cell (MSCs) have become an advanced therapy medicinal product (ATMP) that must be produced following the good manufacturing practice (GMP) standards. We describe the upgrade of our existing clinical-grade MSC manufacturing process to obtain GMP certification. Staff organization, premises/equipment qualification and monitoring, raw materials management, starting materials, technical manufacturing processes, quality controls, and the release, thawing and infusion were substantially reorganized. Numerous studies have been carried out to
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Kierkels, Guido J. J., Trudy Straetemans, Moniek A. de Witte, and Jürgen Kuball. "The next step toward GMP-grade production of engineered immune cells." OncoImmunology 5, no. 2 (2015): e1076608. http://dx.doi.org/10.1080/2162402x.2015.1076608.

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Heshusius, Steven, Esther Heideveld, Patrick Burger, et al. "Large-scale in vitro production of red blood cells from human peripheral blood mononuclear cells." Blood Advances 3, no. 21 (2019): 3337–50. http://dx.doi.org/10.1182/bloodadvances.2019000689.

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Key Points This article provides a defined GMP-grade medium and erythroid culture protocol, resulting in >90% enucleated RBC. This article provides a high-resolution database of RNA expression dynamics at daily intervals during terminal erythroid differentiation.
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Aussel, Clotilde, Elodie Busson, Helene Vantomme, Juliette Peltzer, and Christophe Martinaud. "Quality assessment of a serum and xenofree medium for the expansion of human GMP-grade mesenchymal stromal cells." PeerJ 10 (May 30, 2022): e13391. http://dx.doi.org/10.7717/peerj.13391.

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Background Cell-based therapies are emerging as a viable modality to treat challenging diseases, resulting in an increasing demand for their large-scale, high-quality production. Production facilities face the issue of batch-to-batch consistency while producing a safe and efficient cell-based product. Controlling culture conditions and particularly media composition is a key factor of success in this challenge. Serum and Xeno-Free Media (SXFM) represent an interesting option to achieve this goal. By reducing batch to batch variability, they increase Good Manufacturing Practices (GMP)-complianc
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Chauvierre, Cédric, Rachida Aid-Launais, Joël Aerts, et al. "Pharmaceutical Development and Safety Evaluation of a GMP-Grade Fucoidan for Molecular Diagnosis of Cardiovascular Diseases." Marine Drugs 17, no. 12 (2019): 699. http://dx.doi.org/10.3390/md17120699.

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The adhesion molecule P-selectin is present on the cell surface of both activated endothelium and activated platelets. The present study describes the pharmaceutical development, safety evaluation, and preclinical efficacy of a micro-dosed radiotracer. The macromolecular nanoscale assembly consisted of a natural compound made of a sulfated fucose-rich polysaccharides (fucoidan) and a radionuclide (technetium-99m) for the detection of P-selectin expression in cardiovascular diseases. After extraction and fractionation from brown seaweeds, the good manufacturing practice (GMP) production of a lo
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Rusconi, Giulio, Giuseppe Cusumano, Luca Mariotta, et al. "Upgrading Monocytes Therapy for Critical Limb Ischemia Patient Treatment: Pre-Clinical and GMP-Validation Aspects." International Journal of Molecular Sciences 23, no. 20 (2022): 12669. http://dx.doi.org/10.3390/ijms232012669.

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Advanced cell therapy medicinal products (ATMP) are at the forefront of a new range of biopharmaceuticals. The use of ATMP has evolved and increased in the last decades, representing a new approach to treating diseases that are not effectively managed with conventional treatments. The standard worldwide recognized for drug production is the Good Manufacturing Practices (GMP), widely used in the pharma production of synthesized drugs but applying also to ATMP. GMP guidelines are worldwide recognized standards to manufacture medicinal products to guarantee high quality, safety, and efficacy. In
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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, Eur
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Malthufah, Yeda Rachma Ayu, and Kusuma Scorpia Lestari. "Assisting Food Household Industries in Implementation of Good Manufacturing Practice (GMP) on Frozen Meat Kebab in Sidoarjo District." Media Gizi Kesmas 12, no. 2 (2023): 878–85. http://dx.doi.org/10.20473/mgk.v12i2.2023.878-885.

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Background: Good Manufacturing Practice (GMP) is a reference that explains the procedures to produce processed food so that it is of high quality, safe, and suitable for public consumption. The Food Safety Facilitator's role is to help register the processed products of SME (Small Medium Enterprise) X to obtain an NIE( Nomor Izin Edar) number. Objectives: The SME assistance aims to improve the implementation of GMP so that it can meet the GMP level that meets the requirements of the Regulation of the Head of the Food and Drug Administration on Guidelines for Inspection of Processed Food Produc
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Dissertations / Theses on the topic "Production clinique grade GMP"

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Kouhil, Menasria Naziha. "Islet Cell Purification Systems : Integration of Novel Repurposed GMP Closed-System Technologies from Evaluation to Patent Implementation." Electronic Thesis or Diss., Université de Lille (2022-....), 2024. http://www.theses.fr/2024ULILS083.

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L'optimisation de la purification des cellules d'îlots est essentielle pour faire progresser les thérapies cellulaires ciblant le diabète de type 1, nécessitant l'intégration de technologies innovantes, conformes aux normes GMP, afin de renforcer l'efficacité des processus, l'automatisation et l'évolutivité. Cette thèse analyse deux technologies majeures employées dans la purification des îlots. La première étude examine l'impact d'un nouveau système de refroidissement sur le processus de purification des cellules d'îlots. Ce système permet un contrôle précis de la température durant la purifi
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Laroye, Caroline. "Le cordon ombilical : une source alternative de cellules souches/stromales mésenchymateuses dans le traitement du choc septique ?" Thesis, Université de Lorraine, 2017. http://www.theses.fr/2017LORR0279.

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Le choc septique est actuellement la dixième cause de mortalité à travers le monde à égalité avec les infarctus du myocarde. Sa physiopathologie extrêmement complexe, entrelaçant un état pro-inflammatoire et anti-inflammatoire, rend caduque l’action des thérapeutiques conventionnelles. En ce sens, les recherches s’orientent vers les thérapeutiques innovantes et notamment les cellules souches/stromales mésenchymateuses (CSM). En effet, les études murines ont mis en évidence que les CSM étaient en mesure, notamment par leurs actions paracrines, d’améliorer la survie, la défaillance d’organes mai
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Rothé, Lamia. "Reconstitution immunitaire et immunothérapie adoptive anti-virales après allogreffe de cellules souches hématopoiétiques." Thesis, Nancy 1, 2010. http://www.theses.fr/2010NAN10073/document.

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L’allogreffe de cellules souches hématopoïétiques (CSH) est un traitement efficace des Hémopathies malignes. Cependant, les complications des allogreffes parmi lesquelles les infections virales sont associées parfois à une morbidité et une mortalité importantes. Ces infections surviennent en l’absence de reconstitution immunitaire. Un monitoring régulier de la charge virale des principaux agents infectieux impliqués est réalisé mais amène parfois à la mise en oeuvre abusive de traitements anti-viraux qui ne sont pas dénués de toxicité.Dans ce travail, nous proposons d’associer à ce monitoring
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Book chapters on the topic "Production clinique grade GMP"

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Andriolo, Gabriella, Elena Provasi, Andrea Brambilla, et al. "GMP-Grade Methods for Cardiac Progenitor Cells: Cell Bank Production and Quality Control." In Methods in Molecular Biology. Springer US, 2020. http://dx.doi.org/10.1007/7651_2020_286.

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Conference papers on the topic "Production clinique grade GMP"

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Al-Sulaiti, Asma Mohammed, Moza Al- Khulaifi, Sara Al-Khawaga, Zohreh Calderone, Bella Guerrouahen, and Chiara Cugno. "Adipose Tissue Derived-Mesenchymal Stromal Cell: Setting the ground for Clinical Grade Production at Sidra's GMP Facility." In Qatar Foundation Annual Research Conference Proceedings. Hamad bin Khalifa University Press (HBKU Press), 2018. http://dx.doi.org/10.5339/qfarc.2018.hbpd615.

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Cugno, Chiara, Moza Alkhualifi, Asma Al-Sulaiti, Bella Guerrouahen, Sara Al-Khawaga, and Zohreh Calderone. "Foreskin DerivedMesenchymal Stromal Cell FSKMSC: Setting the ground for the Clinical Grade Production of MSC at Sidra's GMP Facility." In Qatar Foundation Annual Research Conference Proceedings. Hamad bin Khalifa University Press (HBKU Press), 2018. http://dx.doi.org/10.5339/qfarc.2018.hbpd736.

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Adamson, Lars, Dhifaf Sarhan, Bhavesh Choudhary та ін. "Abstract B071: Enhanced IL-12 production and T cell stimulation ability by dendritic cells matured in presence of GMP-grade Toll-like receptor ligands and IFN-γ". У Abstracts: CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference: Translating Science into Survival; September 16-19, 2015; New York, NY. American Association for Cancer Research, 2016. http://dx.doi.org/10.1158/2326-6074.cricimteatiaacr15-b071.

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