Neonatal Dermal Fibroblasts

Overview

RoosterVial™-hDF-CC are off-the-shelf cGMP neonatal foreskin-derived dermal fibroblasts that provide a consistent, well-characterized starting material supporting use in allogeneic cell therapy manufacturing, extracellular vesicle production, cellular reprogramming, and aesthetics.

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 hDFs are compatible with established scalable 2D and 3D protocols to easily manufacture billions of cells or trillions of hDF-EVs and are designed for immediate use in clinical manufacturing.

Product Information Sheet

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 neonatal foreskin donor tissue sourced under GTP standards (listed below)
• Release testing includes: cell count, viability, and flow cytometry for fibroblast surface marker expression (S100A4, CD90, CD142) and negative controls (keratin, CD31).
• Safety testing includes: sterility, endotoxin, mycoplasma, and in vitro adventitious agents*
• Characterization testing includes: G-band karyotyping and population doubling level (PDL)
• >10-fold expansion in 4 to 5 days when cultured with prcRoosterNourish™-MSC-CC
• 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.

*Additional viral testing conducted on Master Cell Bank in accordance with FDA’s Draft Guidance for Industry: “Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products”