RoosterNourish™-MSC-CC

Overview

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.

Product Features

• Manufactured under cGMP, RoosterBasal™-MSC-CC (500 mL) and RoosterBooster™-MSC-CC (10 mL)
• Supported by US FDA Type II Master Files – available for cross reference
• Used with a qualified working cell bank, RoosterNourish™-MSC-CC contributes to an economical cost of goods and dramatically impacts efficiencies in path to commercialization.
• CliniControl™ products achieve clinically-relevant lot sizes (of consistent PDL) in days, not weeks
• Per our process recommendations*, this bioprocess system provides scalable and reproducible expansion of hMSCs
• Preserves key hMSC critical quality attributes – identity and functional characterization
• Supports industry-leading productivity metrics
• For use in cell and cell-free (extracellular vesicle (EV)) applications – including autologous cGMP manufacturing

*Media needs will be dependent on customer’s process.