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Fig. 1 | Journal of Translational Medicine

Fig. 1

From: Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product

Fig. 1

Overview of the manufacturing of expanded Treg cells with in-process tests. Each step of the process validation for Treg cell manufacturing was performed in accordance with GMP guidelines, with the aim of providing documented evidence that the process, performed following specific written procedures, is feasible and reproducible and produces an ATMP that meets predefined quality parameters. The process includes (0) receipt and control of the raw material after confirmation of patient eligibility, (1) depletion of CD8+ cells from a fresh leukapheresis unit, (2) enrichment of CD25+ cells from CD8-depleted fraction, (3) expansion of CD25+ cells for 21 days, (4) bead depletion, (5) cryopreservation of the finished product, and (6) final characterizations of the ATMP and QC testing. Multiple in-process samples (shown on the right) were taken at different stages of the process and submitted for relevant testing. Further details on GMP compliance can be found in the “Process validation design” section in the “Methods” section. Created with BioRender.com [56]

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