RoosterVial™-hUC-DEV+ are off-the-shelf human umbilical cord-derived Mesenchymal Stem/Stromal Cells (hUC-MSCs) that provide a consistent, well-characterized pre-clinical development tool.
Starting with donor tissue sourced under Good Tissue Practice (GTP) standards in accordance with 21 CFR Part 1271, each vial consists of 10M manufactured to a consistent population doubling level. Lot-specific expansion performance testing supports >10-fold expansion within 4–5 days (in RoosterNourish™-MSC-XF) and >20 additional population doublings from thaw.
RoosterVial™-hUC-DEV+ are compatible with established scalable 2D and 3D protocols to easily manufacture billions of cells or trillions of hMSC-EVs and are designed as a cost-effective tool for pre-clinical product and process development.
*RoosterVial-hUC-DEV+ manufactured and sold by RoosterBio, INC and supported by licensed technology from Tissue Regeneration Therapeutics Inc. (TRT) core technology and patent family: US 8,790,923; US 8,278,102; US 7,547,546; US 9,611,456; US 9,611,456; US 8,481,311; US 9,611,456.
Product Features
10M cryopreserved xeno-free cells per vial
Manufactured from normal human umbilical cord [Wharton’s Jelly] sourced under GTP standards (listed below)
Release testing includes: cell count, viability, and flow cytometry for hMSC surface marker expression (CD90, CD166) and negative controls (CD34, CD45)
Expansion protocols do not require media exchanges or surface coatings
Intended Use: Research Use Only
Donor tissues sourced under GTP standards in compliance with applicable requirements of 21 CFR 1271.
Additional viral testing conducted on Master Cell Bank in accordance with FDA’s Draft Guidance for Industry: “Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products”
