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Title: Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing
Author: Perpiñá Martin, Unai
Herranz, Cristina
Martín Ibáñez, Raquel
Boronat, Anna
Chiappe, Felipe
Monforte, Verónica
Orpella Aceret, Gemma
González, Ester
Olivé, Myriam
Castella, Maria
Suñé, Guillermo
Urbano Ispizua, Álvaro
Delgado, Julio (Delgado González)
Juan, Manel
Canals i Coll, Josep M.
Keywords: Fabricació
Control de qualitat de l'assistència mèdica
Teràpia cel·lular
Teràpia genètica
Malalties víriques
Manufacturing processes
Quality control of medical care
Cellular therapy
Gene therapy
Virus diseases
Issue Date: 19-Nov-2020
Publisher: BioMed Central
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.
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It is part of: Translational Medicine Communications, 2020, vol. 5, num. 22
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ISSN: 2396-832X
Appears in Collections:Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)
Articles publicats en revistes (Biomedicina)
Articles publicats en revistes (Institut de Neurociències (UBNeuro))

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