Process data of allogeneic ex vivo-expanded ABCB5+ mesenchymal stromal cells for human use: off-the-shelf GMP-manufactured donor-independent ATMP.

Autor: Ballikaya, Seda, Sadeghi, Samar, Niebergall-Roth, Elke, Nimtz, Laura, Frindert, Jens, Norrick, Alexandra, Stemler, Nicole, Bauer, Nicole, Rosche, Yvonne, Kratzenberg, Vanessa, Pieper, Julia, Ficek, Tina, Frank, Markus H., Ganss, Christoph, Esterlechner, Jasmina, Kluth, Mark A.
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Zdroj: Stem Cell Research & Therapy; 11/16/2020, Vol. 11 Issue 1, pN.PAG-N.PAG, 1p
Abstrakt: Background: Human dermal mesenchymal stromal cells (MSCs) expressing the ATP-binding cassette (ABC) efflux transporter ABCB5 represent an easily accessible MSC population that, based on preclinical and first-in-human data, holds significant promise to treat a broad spectrum of conditions associated not only with skin-related but also systemic inflammatory and/or degenerative processes. Methods: We have developed a validated Good Manufacturing Practice-compliant expansion and manufacturing process by which ABCB5+ MSCs derived from surgical discard skin tissues are processed to an advanced-therapy medicinal product (ATMP) for clinical use. Enrichment for ABCB5+ MSCs is achieved in a three-step process involving plastic adherence selection, expansion in a highly efficient MSC-selecting medium, and immunomagnetic isolation of the ABCB5+ cells from the mixed culture. Results: Product Quality Review data covering 324 cell expansions, 728 ABCB5+ MSC isolations, 66 ABCB5+ MSC batches, and 85 final drug products reveal high process robustness and reproducible, reliable quality of the manufactured cell therapy product. Conclusion: We have successfully established an expansion and manufacturing process that enables the generation of homogenous ABCB5+ MSC populations of proven biological activity manufactured as a standardized, donor-independent, highly pure, and highly functional off-the-shelf available ATMP, which is currently tested in multiple clinical trials. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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