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    RoosterVial™-hBM-20M-CC

    cGMP xeno-free human bone marrow-derived MSCs to support allogenic therapeutic cell manufacturing.

    • SKU/Catalog No: MSC-CC040
    • Components: N/A
    • Unit Size: 1 x 20 million xeno-free (XF) cryopreserved cells
    • Price: Contact us for pricing
    Designed for the regenerative product developer. Fully tested and ready for cGMP manufacturing.
    Overview

    Overview

    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.

    Product Features

    • 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.

    RoosterBio®’s xeno-free (XF) hBM-MSC have a fibroblastic cell morphology (left) and RoosterVial™-hBM-20M-CC (CliniControl™, MSC-CC040) cells express hMSC cell surface markers (right) when cultured in RoosterNourish-MSC-CC (KT-021).
    Immunomodulatory activity (left, IDO activity increase in response to IFN-y) and angiogenic cytokine secretion (right) of a representative RoosterVial™-hBM-20M-CC (MSC-CC040) lot.
    Trilineage differentiation of a representative RoosterVial™-hBM-20M-CC (MSC-CC040) cell lot. Adipogenesis, left; Osteogenesis, middle; Chondrogenesis, right.
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