RoosterVial™-hBM-CC are off-the-shelf cGMP bone marrow-derived human mesenchymal stem/stromal cells that provide a consistent, well-characterized starting material supporting use in allogeneic cell therapy manufacturing and extracellular vesicle production.
Starting with donor tissue sourced under Good Tissue Practice (GTP) standards in accordance with 21 CFR Part 1271, each vial contains 20M cells manufactured to a consistent population doubling level. Lot-specific expansion performance testing supports >10-fold expansion within 4-5 days (in prcRoosterNourish™-MSC-CC) and >20 additional population doublings from thaw.
CliniControl hBM-MSCs are compatible with established scalable 2D and 3D protocols to easily manufacture billions of cells or trillions of hMSC-EVs and are designed for immediate use in clinical manufacturing.
Contact us about off-the-shelf Master Cell Bank (MCB) availability to support gene-modified banks and iPSC reprogramming.
Product Features
20M cryopreserved xeno-free cells per vial
cGMP-manufactured from normal human bone marrow donor tissue sourced under GTP standards (listed below)
FDA Type II Master File in place to streamline regulatory submission
Release testing includes: cell count, viability, and flow cytometry for MSC surface marker expression (CD90 and CD166) and negative controls (CD34 and CD45)
Safety testing includes: sterility, endotoxin, mycoplasma, and in vitro adventitious agents*
Characterization testing includes: G-band karyotyping and population doubling level (PDL), immunomodulatory potential (IDO enzymatic activity), cytokine secretion profile (bFGF, HGF, IL-8, TIMP-1, TIMP-2, and VEGF), and tri-lineage differentiation potential
Expansion protocols do not require media exchanges or surface coatings
Intended Use: For Further Manufacturing Use Only. Not intended for diagnostic use or for direct human or veterinary therapeutic use.
CliniControl™ RoosterVial products are manufactured from tissues sourced under GTP standards and at sites that use methods and controls consistent with current Good Manufacturing Practice (cGMP) for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) in accordance with applicable requirements of 21 CFR 1271. Manufacturing sites are ISO 9001–certified. Contact us for region-specific regulatory support.
*Additional viral testing conducted on Master Cell Bank in accordance with FDA’s Draft Guidance for Industry: “Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products”
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.
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.
