Contamination & Impurity Testing

Contamination & Impurity Testing

From preclinical lots through routine bulk harvest testing of clinical and marketed batches, contamination testing helps ensure the safety of your biologic before it is released for use in animals and humans. The characterization of the purification process and testing for possible impurities are also key parts of the chemistry and manufacturing controls (CMC) section of regulatory filings.

Contamination Detection Assays & Impurity/Residual Testing Services

Charles River offers a portfolio of compendial assays for the detection of mycoplasma and bacterial contaminants and also in vivo, in vitro, and biochemical viral detection assays. Our experts can design and develop the appropriate testing plan for your biologic, with a selection of available and customized assays that suit your specific needs.

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In support of “quality by design” for any process, testing of residual process impurities is an integral step. We support testing of all process stages for impurities such as residual Protein A, DNA, Tween, IPTG, TRIS, PEI, endotoxin, and host cell proteins. In addition to generic methods, we offer transfer or method development and validation for customized, product-specific methods.

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