Raw Material Testing

For the manufacture of biologicals such as recombinant proteins, enzymes, monoclonals and gene therapy vectors, many cell culture systems are used which require additives derived from bovine or porcine origin such as fetal bovine or newborn calf sera, insulin, transferrin, growth factors and trypsin.
Testing the critical raw materials that are used in the biological manufacturing process can greatly minimize the risk of contamination. Even if your process is animal-origin-free, regulators request that manufacturers assure the viral safety of all raw materialsby checking that animal-origin components were not used in any of the materials that go into the manufacture of a raw material.
The key contaminants found in raw materials are:

• Bacteria (mycoplasma)
• Yeast
• Viruses
• Residual DNA (viral, and/or bacterial, and host)
• Endotoxin
• Adventitious agents

At MDS, we offer the following assays for assuring the quality and purity of raw materials used in the production of biologicals for the pharmaceutical and biotech industries.

• Sterility Testing (url)
• Mycoplasma Detection Assays (url)
• Adventitious Virus Testing (url)
• Residual DNA (url)
• Endotoxin Detection, LAL Test (url)
• Bioburden (url)
• Residual DNA (url)
• 9CFR Testing (url)

Regulatory Sites of Interest

• Note for Guidance on the use of Bovine Serum in the Manufacture of Human Biological Medicinal Products (url)
• Code of Federal Regulations Title 9 (9 CFR). Animal and Animal Products Part 113.53 Requirements for ingredients of animal origin used for production of biologics. (url)
• Code of Federal Regulations Title 9 (9 CFR). Animal and Animal Products Part 113.46. Detection of Cytopathogenic and/or Haemadsorbing Agents. (url)
• Code of Federal Regulations Title 9 (9 CFR). Animal and Animal Products Part 113.47 Detection of extraneous viruses by the fluorescent antibody technique. (url)
• FDA Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications(url)
• Code of Federal Regulations Title 9 (9 CFR). Animal and Animal Products Part 113.53 Requirements for ingredients of animal origin used for production of biologics. (url)
• EU Porcine: Concept paper for a guideline on the quality of porcine trypsin used in the manufacture of human biological medicinal products (url)
• FDA Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications (url)

Relevant USP and EP references you may wish to consult:
United States Pharmacopoeia:

• <1024> Bovine Serum
• <1237> Virology test methods
• <1235> Vaccines for human use - general considerations

European Pharmacopoeia:

• 01/2008:2262 Bovine Serum
• 01/2011:50203 5.2.3 Cell Substrates for the Production of Vaccines for Human Use
• 01/2012:0153 Vaccines for Human Use
• 01/2008:50107, 5.1.7 Viral Safety

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