A literature review was conducted with the expression “GMP of ATMPs”, in English and in French between April and May 2023 – updated in June 2024 – in the following databases: Dalloz, HeinOnline, Lexbase, Lexis Nexis, Lextenso, Navis, Doctrinal Plus, Westlaw UK, Brill and Cairn, Bibliothèque numérique en droit de la santé, Wiley Online Library, Lamyline Reflex, Cambridge University Press Revues – Archives ISTEX, De Gruyter revues – Archives ISTEX, Encyclopédie Max Planck de droit international public, JSTOR, Law Review Commons, OpenEdition Journals, ScienceDirect, Springer Nature, Web of Science, Google Scholar and PubMed.
Please find below the most relevant results of this review
GMP Banking of Human Pluripotent Stem Cells: A US and UK perspective – Abranches, Elsa, Sofia Spyrou, and Tenneille Ludwig. Stem Cell Research, 45 (05/2020).
GMP Facilities for Clinical Cell Therapy Product Manufacturing: A Brief Review of Requirements and Design Considerations – Aghayan, Hamid Reza, Babak Arjmand, and Scott R. Burger. Chapter in Perinatal Tissue-Derived Stem Cells: Alternative Sources of Fetal Stem Cells, Stem Cell Biology and Regenerative Medicine, Springer International Publishing, (2016): 215‑227.
GMP Facilities for Manufacturing of Advanced Therapy Medicinal Products for Clinical Trials: An Overview for Clinical Researchers – Alici, Evren, and Pontus Blomberg. Current Gene Therapy 10, no 6 (12/2010): 508‑515. Scientific abstract
About ATMPs, SOPs and GMP: The Hurdles to Produce Novel Skin Grafts for Clinical Use – Hartmann-Fritsch, Fabienne, Daniela Marino, and Ernst Reichmann. « About ATMPs, SOPs and GMP: The Hurdles to Produce Novel Skin Grafts for Clinical Use ». Transfusion Medicine and Hemotherapy 43, no 5 (2016): 344‑352. Scientific abstract
Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting – Iancu, Emanuela M, and Lana E Kandalaft. Current Opinion in Biotechnology, 65 (10/2020): 233‑241. Scientific abstract
GMP Challenges for Advanced Therapy Medicinal Products – Milmo, Sean. Biopharm International 28, no 12 (12/2015): 12‑14.
« La réforme de la législation pharmaceutique communautaire ». Peigné, Jérôme. Revue de droit sanitaire et social, no 3 (09/2004): 577.
Validation of an automated viable cell counting assay for GMP manufacturing of human induced pluripotent stem cells – Peli, Valeria, Mario Barilani, Araceli Rivera-Ordaz, Paolo Manzini, Francesco Rusconi, Cristiana Lavazza, Silvia Cimoni, and Lorenza Lazzari. Biochemical Engineering Journal 196 (07/2023). Scientific abstract
Critical Analysis of cGMP Large-Scale Expansion Process in Bioreactors of Human Induced Pluripotent Stem Cells in the Framework of Quality by Design – Rivera-Ordaz, Araceli, Valeria Peli, Paolo Manzini, Mario Barilani, and Lorenza Lazzari. BioDrugs 35, no 6 (11/2021): 693‑714. Scientific abstract
Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents – Sanz-Nogués, Clara, et Timothy O’Brien. Biomaterials and Biosystems 2 (06/2021). Scientific abstract
Analysis of GMP for Marketing Authorization of ATMPs: Comparison in the US, the EU, Japan and South Korea – Shin, Hocheol, and Eunyoung Kim. Regenerative Medicine 17, no 5 (05/2022). Scientific abstract
Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products – Tulina, M. A., and N. V. Pyatigorskaya. Bulletin of Experimental Biology and Medicine 164, no 4 (03/2018): 579‑582. Scientific abstract.
Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production – Viganò, Mariele, Silvia Budelli, Cristiana Lavazza, Tiziana Montemurro, Elisa Montelatici, Stefania de Cesare, Lorenza Lazzari, Anna Rosa Orlandi, Giovanna Lunghi, and Rosaria Giordano. Stem Cells International 2018 (09/ 2018). Scientific abstract.
Good Manufacturing Practice–compliant change of raw material in the manufacturing process of a clinically used advanced therapy medicinal product–a comparability study – Wixmerten, Anke, Sylvie Miot, Patrick Bittorf, Francine Wolf, Sandra Feliciano, Stephan Hackenberg, Sebastian Häusner, and al. Cytotherapy 25, no 5 (05/2023): 548‑558. Scientific abstract.
See also the literature relevant to Manufacturing authorisation of ATMPs