By Kathryn Martin Remington, Ph.D., Principal Scientist for Clearance Services, BioReliance
Careful design of viral clearance studies is critical, and knowledge of the basic principles behind the procedures and assays used in a viral clearance study will make the development of a successful study much easier. In this series of articles, a variety of topics are discussed that explain the various components of a viral clearance study. This information can be a resource when designing viral clearance studies or interpreting the data from a study. Whether your viral clearance studies are performed by an in-house virology group or by a contract laboratory, a good understanding of the fundamentals of the clearance study is essential for ensuring that the study meets its intended goals. In this second article of the series, pre-study experiments will be explained.