Certificates of Analysis, handling protocols, and characterization reference material published by MSC Centers for UCT-MSCs and MSC-derived exosomes.
Every lot ships with a full Certificate of Analysis. This reference breaks down each assay in the panel: post-thaw viability (trypan blue exclusion), sterility (USP <71>), endotoxin (LAL), mycoplasma (PCR), flow cytometry surface markers (CD73+, CD90+, CD105+, CD45-, CD34-), and NTA particle count, with the threshold values and release criteria used to accept or reject a lot.
Standard operating procedure for rapid thaw, wash, and resuspension of cryopreserved UCT-MSC vials: equipment requirements, timing checkpoints, quality verification steps, and the handling errors most likely to reduce viability.
Liquid nitrogen storage (-196°C) for long-term holding, vapor phase (-150°C to -190°C) for short-term holding, and why ultra-low freezers (-80°C) are not suitable for extended UCT-MSC storage. Exosome preparations follow a separate -80°C protocol with a defined freeze-thaw limit.
Complete technical specifications for MSC-derived exosome preparations: storage conditions (-80°C), aliquoting strategy, reconstitution protocol, visual quality indicators, and application-specific dosing considerations. Preparations tolerate up to 3 freeze-thaw cycles when properly aliquoted before the initial freeze.
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