Virus and TSE Validations

Process Validation studies are designed to assure the removal and/or inactivation of viruses during the purification process. It is the third of the three critical and complementary approaches used to assure the viral safety of a biotechnology product.  First cell lines and raw materials are tested for freedom from viruses.  Second, release testing programs are performed to assess the presence of viruses in the unpurified bulk product and their absence in the purified final product.  And finally, a purification process validation is performed to assess viral clearance.

Process Validation studies include:

1. selecting appropriate process steps for evaluation through an analysis of risk,
2. scaling down the selected process steps,
3. selecting the viruses to be evaluated,
4. performing the studies,
5. evaluating the results in a report suitable for submission relevant to the regulatory authority in the US or Europe.

Process Validation addresses issues related to different product types, such as monoclonal antibodies, gene therapy and cell products, recombinant proteins, and vaccines. RNA- and DNA-enveloped and non-enveloped viruses are incorporated into Viral Clearance protocols.

TSE Validations

Charles River has extensive experience conducting TSE validation studies, with the first studies performed over 15 years ago.Weoffer a choice of validations using mouse scrapie models with both bioassay and Western blot immunoassay detection methods.

Raw Material Testing

Our Biosafety Testing and Analytical Chemistry Program includes validated assay protocols for the most commonly used raw materials. We extend a service designed to develop and validate “raw material specific” assays, customized to meet your specific production process.

Data Sheet: Viral Clearance Studies

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