hBM-20M-CC (MSC-CC040)">

RoosterVial™-hBM-20M-CC (MSC-CC040)

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Xeno-Free Human Bone Marrow-Derived MSCs

Revolutionizing the Regenerative Medicine (RM) industry, one MSC product at a time. The industry’s only high-quality allogeneic, off-the-shelf working cell bank (WCB) for therapeutic cell manufacturing is here.  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 Quality and Regulatory documentation to support and simplify IND filings.  By providing high-volume, well-characterized, standardized working cell banks (WCBs) for large scale stem cell manufacturing and by establishing a new comprehensive and qualified stem cell supply chain, (encompassing donor and cell bank testing, qualification, and release), RoosterBio is reducing redundancy while driving efficiency and standardization in the industry.  Select off-the-shelf cGMP hMSC populations to bypass major steps in clinical manufacturing.

Product at a Glance:

  • At least 20 million XF cells per vial
  • Manufactured under cGMP conditions
  • Cryopreserved using a controlled and fully XF preservation process
  • Tissue of Origin: Healthy human bone marrow
  • Well-characterized; supported by detailed functional data
  • Use with CliniControl™ bioprocess medium (RoosterNourish™-MSC-CC) for an anticipated lot size yield of approximately 3-5 Billion hMSCs per our process recommendation*
  • Media needs will be dependent on customer’s process. Contact us for process recommendations.
  • The XF hBM-MSC Pre-Clinical Development Kit (KT-023) is a Research Use Only (RUO) kit. Perform pre-clinical studies with comparable materials and similar process recommendations.

 

Intended Use: For Further Manufacturing Use Only. Not intended for diagnostic use or for direct therapeutic human or veterinary use.


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