Potency assay to predict the anti-inflammatory capacity of a cell therapy product for macrophage-driven diseases: overcoming the challenges of assay development and validation

Autor: Sadeghi, Samar, Nimtz, Laura, Niebergall-Roth, Elke, Norrick, Alexandra, Hägele, Stefan, Vollmer, Lena, Esterlechner, Jasmina, Frank, Markus H., Ganss, Christoph, Scharffetter-Kochanek, Karin, Kluth, Mark Andreas

Publikováno v: In Cytotherapy May 2024 26(5):512-523

Process development and safety evaluation of ABCB5⁺ limbal stem cells as advanced-therapy medicinal product to treat limbal stem cell deficiency.

Autor: Norrick, Alexandra¹ (AUTHOR), Esterlechner, Jasmina¹ (AUTHOR), Niebergall-Roth, Elke¹ (AUTHOR), Dehio, Ulf² (AUTHOR), Sadeghi, Samar¹ (AUTHOR), Schröder, Hannes M.² (AUTHOR), Ballikaya, Seda¹ (AUTHOR), Stemler, Nicole¹ (AUTHOR), Ganss, Christoph^1,2 (AUTHOR), Dieter, Kathrin² (AUTHOR), Dachtler, Ann-Kathrin² (AUTHOR), Merz, Patrick^3,4 (AUTHOR), Sel, Saadettin⁴ (AUTHOR), Chodosh, James⁵ (AUTHOR), Cursiefen, Claus^6,7 (AUTHOR), Frank, Natasha Y.^8,9,10,11 (AUTHOR), Auffarth, Gerd U.^3,4 (AUTHOR), Ksander, Bruce¹² (AUTHOR), Frank, Markus H.^10,11,13,14 (AUTHOR), Kluth, Mark A.^1,2 (AUTHOR) andreas.kluth@ticeba.com

Publikováno v: Stem Cell Research & Therapy. 3/19/2021, Vol. 12 Issue 1, p1-21. 21p.

Additional file 1 of Process development and safety evaluation of ABCB5+ limbal stem cells as advanced-therapy medicinal product to treat limbal stem cell deficiency

Autor: Norrick, Alexandra, Esterlechner, Jasmina, Niebergall-Roth, Elke, Dehio, Ulf, Sadeghi, Samar, Schröder, Hannes M., Ballikaya, Seda, Stemler, Nicole, Ganss, Christoph, Dieter, Kathrin, Ann-Kathrin Dachtler, Merz, Patrick, Sel, Saadettin, Chodosh, James, Cursiefen, Claus, Frank, Natasha Y., Auffarth, Gerd U., Ksander, Bruce, Frank, Markus H., Kluth, Mark A.

Additional file 1: Table S1. Tests and specifications for drug substance batch and final drug product release. Table S2. Antibodies used for immunofluorescence evaluation. Table S3. Primers and probes. Table S4. Main inclusion and exclusion criteria

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Additional file 2 of 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.

Additional file 2 : Fig. S1. Photographic documentation of the cell monolayer at 70% confluency. Original total magnification × 200. Fig. S2. Tube formation assay on extracellular matrix gel. ABCB5+ mesenchymal stem cells (1 × 105 and 1.5 × 105) w

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0df5526e401ef5ae6ea4124707271cfb