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Drug Regulatory-Compliant Validation of a qPCR Assay for Bioanalysis Studies of a Cell Therapy Product with a Special Focus on Matrix Interferences in a Wide Range of Organ Tissues by Hannes M. Schröder, Elke Niebergall-Roth, Alexandra Norrick, Jasmina Esterlechner, Christoph Ganss, Markus H. Frank, Mark A. Kluth
Published 2023-07-01
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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 by Seda Ballikaya, Samar Sadeghi, Elke Niebergall-Roth, Laura Nimtz, Jens Frindert, Alexandra Norrick, Nicole Stemler, Nicole Bauer, Yvonne Rosche, Vanessa Kratzenberg, Julia Pieper, Tina Ficek, Markus H. Frank, Christoph Ganss, Jasmina Esterlechner, Mark A. Kluth
Published 2020-11-01
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Process development and safety evaluation of ABCB5+ limbal stem cells as advanced-therapy medicinal product to treat limbal stem cell deficiency by Alexandra Norrick, Jasmina Esterlechner, Elke Niebergall-Roth, Ulf Dehio, Samar Sadeghi, Hannes M. Schröder, Seda Ballikaya, Nicole Stemler, Christoph Ganss, Kathrin Dieter, Ann-Kathrin Dachtler, Patrick Merz, Saadettin Sel, James Chodosh, Claus Cursiefen, Natasha Y. Frank, Gerd U. Auffarth, Bruce Ksander, Markus H. Frank, Mark A. Kluth
Published 2021-03-01
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