The characterization of the purification process is a key part of the chemistry, and manufacturing and controls (CMC) section of regulatory filings. In support of “quality by design” for any process, testing of residual process impurities is an integral step. We have the capabilities to support testing of all process stages for impurities such as residual Protein A, DNA, Tween, IPTG, TRIS, PEI, endotoxin and host cell proteins. Generic methods are offered, as well as transfer or method development and validation for customized, product-specific methods.

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Contamination Testing

Charles River offers a portfolio of compendia assays for the detection of mycoplasma and bacterial contaminants and also in vivo, in vitro and biochemical viral detection assays.

Protein Characterization

We specialize in a broad range of analytical testing techniques to support characterization and development of both recombinant protein and peptide therapeutics.

Cell Banking

Charles River is a partner you can trust to ensure the quality, consistency and integrity of your cell banks.

Viral Clearance

Using a customized approach, we are able to provide technical advice and regulatory support to ensure that a successful and cost-effective viral clearance program is established executed.