A cGMP fed-batch bioreactor feed with pathogen reduced components for hMSC manufacturing.
prcRoosterReplenishTM-MSC-CC is a xeno-free (XF), GMP concentrated bioreactor feed for use in fed-batch hMSC manufacturing bioreactor processes to eliminate media exchanges during rapid expansion of human MSCs for clinical allogeneic and autologous therapeutic cell manufacturing.
Engineered to achieve high cell growth in scalable (>50L) microcarrier-based suspension cultures when paired with our CC RoosterVial™-MSCs and prcRoosterNourish-MSC-CC while reducing contamination risks associated with in-process manipulation. prcRoosterReplenish-MSC-CC boosts media productivity (millions of cells produced per Liter of media consumed) by up to 70%, with each 100 ml bagged unit supplementing 5L of bioreactor expansion media.
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 Type II 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.
*’prc’ denoted products have been manufactured using pathogen reduced components to meet evolving regulatory needs and standards.
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