cGMP xeno-free human bone marrow-derived MSCs to support allogenic therapeutic cell manufacturing.
Using a comprehensive and qualified supply chain of our high volume, well-characterized, and standardized WCBs (working cell banks) for large scale cell manufacturing – you’re now able to bypass major steps in cGMP 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 then scale with your clinical progression to meet your lot size requirements.
A high quality allogeneic, off-the-shelf WCB for therapeutic cell manufacturing, CliniControl™ (CC) bone marrow-derived hMSCs are manufactured with methods and controls that conform with current Good Manufacturing Practices (cGMP) and are supported for use as a manufacturing starting 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.
To further accelerate your translational research, this clinically-relevant WCB can be tested in development prior to cGMP manufacturing.
Intended Use: For Further Manufacturing Use Only. Not intended for diagnostic use or for direct human or veterinary therapeutic use.
*Media needs will be dependent on customer’s process.
Login to search Certificates of Analysis and Quality Control Briefs.