학술논문
A cell bank paradigm for preclinical evaluation of an analogous cellular product for an allogeneic cell therapy.
Document Type
Academic Journal
Author
Nordberg RC; Department of Biomedical Engineering, 3131 Engineering Hall, University of California, Irvine, CA 92617, United States of America.; Donahue RP; Department of Biomedical Engineering, 3131 Engineering Hall, University of California, Irvine, CA 92617, United States of America.; Espinosa MG; Department of Biomedical Engineering, 3131 Engineering Hall, University of California, Irvine, CA 92617, United States of America.; Concordia University Irvine, 1530 Concordia West, Irvine, CA 92612, United States of America.; Salinas EY; Department of Biomedical Engineering, 3131 Engineering Hall, University of California, Irvine, CA 92617, United States of America.; Hu JC; Department of Biomedical Engineering, 3131 Engineering Hall, University of California, Irvine, CA 92617, United States of America.; Athanasiou KA; Department of Biomedical Engineering, 3131 Engineering Hall, University of California, Irvine, CA 92617, United States of America.
Source
Publisher: IOP Pub Country of Publication: England NLM ID: 101521964 Publication Model: Electronic Cited Medium: Internet ISSN: 1758-5090 (Electronic) Linking ISSN: 17585082 NLM ISO Abbreviation: Biofabrication Subsets: MEDLINE
Subject
Language
English
Abstract
Toward the translation of allogeneic cell therapy products, cell banks are needed not only to manufacture the final human product but also during the preclinical evaluation of an animal-based analogous cellular product (ACP). These cell banks need to be established at both the master cell bank (MCB) level and the working cell bank (WCB) level. Inasmuch as most of the development of cell therapy products is at academic centers, it is imperative that academic researchers understand how to establish MCBs and WCBs within an academic environment. To illustrate this process, using articular cartilage as the model, a cell bank for an ACP was developed (MCBs at passage 2, WCBs at passage 5) to produce self-assembled neocartilage for preclinical evaluation (constructs at passage 7). The cell bank system is estimated to be able to produce between 160 000 and 400 000 constructs for each of the six MCBs. Overall, the ACP cell bank yielded constructs that are analogous to the intended human product, which is critical toward conducting preclinical evaluations of the ACP for inclusion in an Investigational New Drug application to the FDA.
(© 2024 IOP Publishing Ltd.)
(© 2024 IOP Publishing Ltd.)