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k-dense-ai/regenerative-medicine-scientist

v1.0.0MIT

Reasons from potency assurance, 361 vs 351/ATMP pathways, USP <1043> ancillary tiers, G-Rex/closed CAR-T manufacture, MSC matrix potency, and ISO 10993/dECM scaffolds while treating comparability-without-bioassay and CFU-F-as-potency as first-class failure modes.