At BioReliance, we offer a wide range of assays and services aimed at ensuring the quality and purity of raw materials used in the production of biologicals for the pharmaceutical and biotech industries.
Whenever animal derived material is used in development or manufacturing (cell lines, serum etc), the risk of contamination with adventitious agents must be considered.
For this reason, not only products that are produced from animal derived material are at risk, but also products that have used animal derived material in their manufacture. Therefore, testing animal derived raw materials used in manufacturing is critical.
We offer the following services and assays for Raw Material Testing:
Custom raw materials testing services also are available. Contact BioReliance and our research team will be happy to assist you in planning your biological production methodology.
What are Raw Materials?
Many cell culture systems used in the manufacture of biologicals such as recombinant proteins, enzymes, monoclonals, and gene therapy vectors require additives derived from bovine or porcine origin such as fetal bovine or newborn calf sera, insulin, transferrin, various growth factors and trypsin.
Bacteria (mycoplasma), yeast, and viruses are known to contaminate these raw materials and can be passed along to patients during the production of biologicals.
Specifically for the presence of bovine and porcine viruses, BioReliance offers in vitro assays as described in the 9CFR Bulletin.
In addition, Residual DNA and Endotoxin are key contaminants found in raw materials. Residual DNA might include both viral, bacterial, and host cell DNA that can be harmful to humans. Endotoxin is produced by bacteria and cause shock or autoimmune response in patients if undetected.
BioReliance offers well tested assays for both Endotoxin testing and Residual DNA.
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