Quality Control of Human Pluripotent Stem Cell-Derived Retinal Pigment Epithelium Cells for Regenerative Therapy
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| Year of publication | 2024 |
| Type | Conference abstract |
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| Description | Human retinal pigment epithelial (RPE) cells form a monolayer of polarized pigmented epithelial cells located between the blood vessels of the eye and the neural retina. The key function of RPE cells is the maintenance and protection of light-sensitive photoreceptors. Degeneration of RPE cells accompanies age-related eye diseases and can lead to the loss of vision. The rescue of the patient´s vision can be achieved by the replacement of the RPE cells. Therefore, we aim to differentiate human embryonal stem cells and human induced pluripotent stem cells into fully functional RPE cells that would be suitable for regenerative therapy. To ensure the RPE cells are not released for the treatment of the patient until the quality has been considered satisfactory, we designed a panel of quality control tests that characterize a) functionality: phagocytosis, specific cytokine secretion, b) morphology, c) identity and viability: marker detection by immunocytochemistry and flowcytometry, d) immunogenicity: lymphocyte-graft cell immune reaction, HLA expression of RPE cells. These tests are prepared for translation into advanced therapy medicinal product (ATMP) manufacture according to good manufacturing practice (GMP). |
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