A cGMP bioprocess medium to support allogeneic and autologous therapeutic cell manufacturing.
RoosterNourish™-MSC-CC is a standardized, xeno-free (XF) bioprocess medium engineered for batch (2D) and fed-batch (3D) culture of hMSCs in allogeneic and autologous therapeutic cell manufacturing. With a rapid 2D process and path to Phase 1 – using 20 x 10-layer vessels, CliniControl™ hMSCs and media get you to the clinic, faster. And, once you’re there, CliniControl scales with your clinical progression – taking you from a lot size of 3-5B hMSCs to ≥30B hMSCs.
CliniControl bioprocess media are manufactured with methods and controls that conform with current Good Manufacturing Practices (cGMP) and are supported for use as an ancillary material by a Master File on file with the FDA. Time spent on investigational new drug (IND) submissions is significantly reduced by facilitating CMC documentation.
Intended Use: For Further Manufacturing Use Only. Not intended for diagnostic use or as an excipient for direct human or veterinary therapeutic use.
*Media needs will be dependent on customer’s process.
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