RoosterBank™-hBM-100M-XF is a closed-system working cell bank of 100M Human Bone-Marrow Derived Mesenchymal Stem/Stromal Cells (hBM-MSCs) isolated from normal healthy adult donors under xeno-free (XF) conditions. This novel, single-use working cell bank is designed to be directly seeded into suspension bioreactors, and enables streamlined, closed-system hMSC manufacturing by providing 100M hBM-MSCs in a cryopreservation bag that can efficiently and economically reach billions of cells. Our XF hBM-MSCs are isolated from adult human iliac crest and expanded from a variety of normal, healthy donors to a population doubling level (PDL) of 8-10, post-mononuclear cell isolation. Each produced lot is released based on ISCT minimal criteria for hMSC identity including cell surface marker expression and tri-lineage differentiation potential, expansion potential, and sterility. Accompanying QC brief contains industry-leading functional characterization including immunomodulatory potential (IDO assay) and angiogenic cytokine secretion, giving added confidence in quality, reproducibility, and east of integration.
RoosterBank™-hBM-100M-XF provides researchers and product developers with a standardized, bioreactor-ready option to scale-up or scale-out to billions of cells, all while utilizing translation-friendly, XF starting materials. Supported by our 2D and our 3D bioreactor processes, RoosterBank™-hBM-100M-XF can efficiently get you to billions of hMSCs to “Radically Simplify” your Research and Product Development.
Product Features
Working cell bank of 100M XF hBM-MSCs per bag
Fill volume (cell solution): 10-12 mL
Single-use cryopreservation bag comprised of USP Class VI fluorinated ethylene propylene (FEP) material and weldable tubing
Closed-system, bioreactor-ready
Efficiently and economically reach billions of cells at a consistent PDL
Supported by vial to bag comparability data
Supported with industry-leading identity and functional characterization
Provides a direct path to scalable development
With RoosterNourish™-MSC-XF and our fed-batch bioreactor feed, RoosterReplenish™-MSC-XF, supports a scale-up process from small scale testing, through development and onto large-scale runs –minimal optimization required between scales
Ships in a cassette for convenient storage
Manufactured with scalable processes & cryopreserved using standard, controlled processes
Intended Use: Research Use Only
CryoCassette for storage and shipping of RoosterBank-hBM™-100M-XF (MSC-035).
Bagged RoosterBank-hBM™-100M-XF and CryoCassette.
RoosterBio®’s hBM-MSC-XF (xeno-free) cultured in RoosterNourish™-MSC-XF (KT-016) have a fibroblastic cell morphology (left) and RoosterBank-hBM™-100M-XF (xeno-free, MSC-035) cells express hMSC cell surface markers (right).
Immunomodulatory activity (left, IDO activity increase in response to IFNy) and angiogenic cytokine secretion of a representative RoosterBank™-hBM-100M-XF (MSC-035) lot (right).
Trilineage differentiation of RoosterBank™-hBM-100M-XF (MSC-035) of a representative MSC-035 lot. Adipogenesis, left; Osteogenesis, middle; Chondrogenesis, right.
