Our cGMP fibronectin delivers the best in safety and consistency.

Akron Bio’s Human Fibronectin Solution, Virus Inactivated is manufactured, tested, and released following relevant cGMP guidelines for ancillary materials and is specifically formulated for cell and gene therapy manufacturing applications. It is supported by a Type II Master File (MF) on file with the FDA which can be referenced during your drug or biologic application process. Eligibility confirmation has also been granted by Japan’s PMDA for use in cellular and tissue-based products.

This product leverages pharmaceutically licensed virus and prion inactivated plasma as a raw material, offering greater batch-to-batch consistency and a unique safety profile. Akron’s Human Fibronectin Solution, Virus Inactivated is purified from this raw material using a sterilized gelatin resin derived from a pharmaceutical-grade polygeline solution.

Donor Eligibility

• Pharmaceutically licensed, pooled plasma from US-licensed plasma donation centers
• Donor screening and virus testing per 21 CFR 610.40
• Nucleic Acid Testing (NAT) conducted for HIV, B19V, HAV, HBV, HCV, & HEV

Raw Material

• Solvent Detergent (S/D) treatment for virus inactivation of enveloped viruses
• Immune Neutralization for inactivation of certain non-enveloped viruses
• Affinity Chromatography to reduce prion proteins
• Sterile microfiltration to minimize the presence of bacteria and parasites

Manufacturing

• Type II eCTD MF (#028120) on file with FDA
• PMDA (Japan) Eligibility Confirmed (No. 1205004)
• Affinity chromatography ligand and sterilized gelatin resin derived from pharmaceutical-grade polygeline solution
• Sterile microfiltration followed by aseptic filling

Quality

• Relevant cGMP guidelines used in manufacture, testing, and release
• USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
• ISO 13485:2016, Medical devices – Quality Management Systems – Requirements for Regulatory Purposes
• ISO/TS 20399-1-3:2018, Biotechnology – Ancillary Materials Present During the Production of Cellular Therapeutic Products
• Mycoplasma, Endotoxin, and Sterility testing per USP/EP

Stability

• Currently on a long-term stability program
• Store at -20 °C
• Transport on dry ice
• Avoid repeated freeze-thaw cycles

For Use Statement

For research or further manufacturing use in ex vivo cell therapy applications. This product is not intended for direct in vivo use or for direct clinical use as a drug, therapeutic, biologic, or medical device.