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


ABSTRACT: 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.

SUBMITTER: Ballikaya S 

PROVIDER: S-EPMC7667860 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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

Ballikaya Seda S   Sadeghi Samar S   Niebergall-Roth Elke E   Nimtz Laura L   Frindert Jens J   Norrick Alexandra A   Stemler Nicole N   Bauer Nicole N   Rosche Yvonne Y   Kratzenberg Vanessa V   Pieper Julia J   Ficek Tina T   Frank Markus H MH   Ganss Christoph C   Esterlechner Jasmina J   Kluth Mark A MA  

Stem cell research & therapy 20201116 1


<h4>Background</h4>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.<h4>Methods</h4>We have developed a validated Good Manufacturing Practice-compliant expansion and manufac  ...[more]

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