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clock Created with Sketch. 05/06/24
12:45
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Originally posted by Blinger:
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and for the unintellectual juveniles still spreading FUD on iPSCs being cancer forming cells. ie: Fear based ignoramuses.To avoid the risk of teratoma formation or aberrant differentiation in vivo, the CYP-001 manufacturing process was designed to ensure the absence of residual iPSCs in the final product by incorporation of the following steps : (1) after the induction of mesoderm, cells were cultured in a single-cell suspension in semisolid medium, which does not support iPSC survival; (2) cells were passed through a mesh filtration step, which eliminates small clumps of undifferentiated iPSCs; and (3) iPSC-derived MSCs were expanded in adherent cell culture conditions, which do not support survival or expansion of undifferentiated iPSCs ." " To confirm these mitigation steps, we conducted an experiment in which undifferentiated iPSCs were seeded in place of MSC progenitor cells in the M-CFM culture step. After culturing for a duration equivalent to that of the differentiation process, cells were collected and cultured under conditions that support the growth and expansion of human pluripotent stem cells. No iPSC colony formation was observed (lower limit of detection, 0.001%), and microscopic observations detected only single dead cells that did not attach or divide in the flowthrough fraction plated. We conclude that residual iPSCs do not survive M-CFM culture , and that any dead iPSCs in this culture are removed before the MSC expansion stage of the process, providing reassurance that the final CYP-001 product is free from residual iPSCs."
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Plus we have real world data of approx 500 doses administered.
(20min delay)