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Biotechnology Services
Process Validation for Viral Clearance |
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Operational Considerations
- Process scale-down: The US and European regulations require that the data provided on validity of scale-down should be satisfactory, and it will be necessary to compare the behavior of the scaled-down and full-scale processes. The scale-down ratio does not need to be the same for all parts of a process. Covance can provide help in selecting appropriate choices throughout the testing phases.
- Cytotoxicity and viral interference studies: It is important to determine the toxicity of the solutions used in the process and their potential for assay interference before starting the validation. Covance has available a number of methodologies that can significantly reduce the toxicity of buffers and that are transparent to the purification process. This enables the potential demonstration of higher magnitude virus clearance data.
- Selection of stages for validation: Selection of two process steps that clear virus by different chemical or physical means allows multiplication of the reductions in viral titre to arrive at a total clearance factor. With our long and varied experience of process validation, Covance can advise on the best approach when choosing which virus to validate with which steps.
- Validation of assays: Covance has spent considerable time and effort to ensure that assays meet the latest requirements for validation.
- Statistical analysis: Statistical analysis of results is carried out for all studies, to provide confidence limits and for reported data and for sampling. The analyses used meet all international regulatory requirements and have been verified by Covance's Statistics Department.
- Choice of virus: The purification process should be validated for the clearance of a range of viruses. The determination of which viruses to use involves consideration of many factors. Covance has not only the expertise to guide you in your choice, but also an extensive range of high-titre viruses for use in the analysis.
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