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    RoosterNourish™-MSC-CC

    A cGMP bioprocess medium to support allogeneic and autologous therapeutic cell manufacturing.

    • SKU/Catalog No: KT-021
    • Components: SU-019; SU-022
    • Unit Size: 500mL bottle of RoosterBasal™-MSC-CC and 10mL bottle of RoosterBooster™-MSC-CC
    High productivity and seamless 2D to 3D culture. This medium was designed for allogeneic and autologous manufacturing processes.
    Overview

    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.

    RoosterFile™ Docs

    RoosterFile™ Docs

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