Neonatal Dermal Fibroblasts

Overview

RoosterVial™-hDF-DEV+ are off-the-shelf neonatal foreskin-derived dermal fibroblasts 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™-hDF-DEV+ are compatible with established scalable 2D and 3D protocols to easily manufacture billions of cells or trillions of hDF-EVs and are designed as a cost-effective tool for pre-clinical product and process development.

Product Information Sheet

Click here for cGMP RoosterVial-hDFs.

Product Features

• 10M cryopreserved xeno-free cells per vial
• 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, and mycoplasma
• Characterization testing includes: population doubling level (PDL)
• >10-fold expansion in 4 to 5 days when cultured with RoosterNourish^™-MSC-XF
• 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Additional viral testing conducted on Master Cell Bank in accordance with FDA’s Draft Guidance for Industry: “Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products”