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Biotechnology Services
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Process Validation for Viral Clearance
The regulations for licensing of biopharmaceuticals recommend that the cell banks, additives and bulk unpurified product be tested for viral safety. By thorough testing, it is possible to demonstrate that no detectable virus is present. It is also necessary to validate the purification process for viral clearance. Process validation for viral clearance is carried out by a dedicated team within Biotechnology Services at Covance Harrogate. The team has over a decade of experience of performing process validations. During this period of operations, we have carried out more than 120 validations covering a wide variety of products produced by rDNA technology, hybridomas and immortalized cells and from human and animal plasma as well as products intended for xenotransplant. We have built up a very large database of viral clearance results in a wide range of process steps and matrices. This experience enables us to provide informed opinion and advice in the design of studies, relevant process steps to validate and choice of virus. Traditionally, infectivity assays have been used to evaluate viral clearance. This continues today but in addition Covance has gained significant experience in the application of quantitative PCR to monitor viral removal and to complement infectivity assay data. Topics discussed below include:
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