Automated manufacturing for iPSC-derived retinal pigment epithelial cells
January 27-31, 2019
Cell manufacturing, which is the most critical steps to realize the transplant of cell-based products for cell therapy or regenerative medicine, will be done in terms of safety, stably and cost-saving under the aseptic environment in the cell processing facility (CPF). The cell processing is regarded as the system consisting of target process, input and output, and there are several fluctuations derived from extrinsic noises (environmental errors) against the system, input quality such as starter cells and materials (medium, reagents, substrate, vessel etc.), and intrinsic disorders (in-process errors) from the behavior variance in manual operation (Fig.1). Especially, intrinsic disorders cause the difficulty to make consistency and robust process for stable quality because the cells have uncertainty accompanied by time-dependent and time-delay properties. Therefore, environmental, material, and operational standardizations are required to realize consistency of processes. In addition, long manufacturing period and small lot size for cell production make the low productivity, causing the high cost production.
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Masahiro Kino-oka, "Automated manufacturing for iPSC-derived retinal pigment epithelial cells" in "Advancing Manufacture of Cell and Gene Therapies VI", Dolores Baksh, GE Healthcare, USA Rod Rietze, Novartis, USA Ivan Wall, Aston University, United Kingdom Eds, ECI Symposium Series, (2019). http://dc.engconfintl.org/cell_gene_therapies_vi/44