RoosterVial-hBM-20M-CC - Model cGMP - MSC-CC040 -Xeno-Free Human Bone Marrow-Derived MSCs
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.
- 20M cryopreserved XF cells per vial – manufactured under cGMP
- Off-the-shelf WCB – bypasses the need of qualifying and releasing an MCB (master cell bank) and WCBs
- Industry-leading functional characterization
- Tissue of Origin: Healthy human bone marrow
- Supported by a US FDA Type II Master File – available for cross reference
- RoosterVial™-hBM-20M-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
- Use with CliniControl™ bioprocess medium for an anticipated lot size yield of more than 3B hMSCs per our process recommendations
- Seamless 2D (batch) to 3D (fed-batch) culture
- Multiple donors available
- Cryopreserved using a controlled and fully XF preservation process
*Media needs will be dependent on customer’s process.