Contamination Detection Assays & Impurity/Residual Testing Services

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


Viral Contamination Detection
Using High-throughput Sequencing (HIT)

 

a strand of human DNA

HTS is an extremely sensitive test providing a broad range of detection for viral contamination of biological products.

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Charles River's impurity testing services offer a portfolio of compendia 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 contamination testing plan for your biologic, with a selection of available and customized assays that suit your specific needs. We support testing of all process stages for impurities, including residual Protein A, DNA, Tween, IPTG, TRIS, PEI, endotoxin, and host cell proteins.


Charles River's Impurity Testing Offerings

With a range of state-of-the-art equipment we provide thorough client-specific analysis of impurities and raw materials testing. Additionally, we offer transfer or method development and validation for customized, product-specific methods

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Frequently Asked Questions (FAQs) About Contamination Testing

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