Molecular Diagnostics Services, Inc.
A Contract Research Organization

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:

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.

Regulatory Sites of Interest

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

European Pharmacopoeia:

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