Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing
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(2020) 5:22
RESEARCH
Translational Medicine Communications
Open Access
Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing Unai Perpiñá1,2,3,4, Cristina Herranz1,2,3,4, Raquel Martín-Ibáñez1,2,3,4,5, Anna Boronat4,6, Felipe Chiappe1,2,3,4, Verónica Monforte1,2,3,4, Gemma Orpella-Aceret1,2,3,4, Ester González1,2,3,4, Myriam Olivé1,2,3,4, María Castella4,7,8, Guillermo Suñé4,7, Álvaro Urbano-Ispizua4,7,9,10, Julio Delgado4,7,9,11, Manel Juan4,6,9,12 and Josep M. Canals1,2,3,4*
Abstract Background: Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods: Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. Results: All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions: Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials. Keywords: ATMP, Good Manufacturing Practices, Cell therapy, Gene therapy, HEK293T, CAR-T, lentivirus
* Correspondence: [email protected] 1 Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Laboratory of Stem Cells and Regenerative Medicine, Institute of Neurosciences, University of Barcelona, C/ Casanova 143, 08036 Barcelona, Spain 2 Production and Validation Center of Advanced Therapies (Creatio), Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, pr
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