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European Biopharmaceutical Review

reviews Recent BSE Concerns and the Relevance of Clearance Studies

The announcement that bovine spongiform encephalopathy (BSE) was found in one cow located in the state of Washington in the US caused quite a furore (1). Some countries went so far as to propose banning all US-made health care products. Immediately, sponsors who knowingly used serum produced from US cows began to assess their need to perform transmissible spongiform encephalopathy (TSE) clearance studies. Others began frantically searching archived records to determine if their products had ever been in contact with US bovine products. Many began immediate planning for TSE clearance studies.

A risk assessment may show that extensive clearance studies are in fact not needed. It is essential to address the current concerns related to one US case of BSE in a rational fashion. A risk assessment that includes consideration of relevant safety issues can provide insight into the most appropriate approach to a timely and cost-effective solution. Consideration of the following questions may be useful in such a risk assessment:

What is the risk of the product transmitting BSE to humans?
Are there already appropriate controls and methods in place that eliminate theoretical risks?
What are the current regulatory expectations?
If a clearance evaluation study is appropriate, what are the issues that must be considered?

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By Gail Sofer, Director of Regulatory Services at BioReliance

Gail Sofer has been with BioReliance since 1998, where she is responsible for providing regulatory services to clients and internal staff. Publications include numerous articles and book chapters on downstream processing, virus inactivation and validation. She has also co-edited and authored several books. She serves on the Science Advisory Board of PDA, the Editorial Advisory Boards of several biotech journals and the Scale-up Advisory Board of Genetic Engineering News. She chairs a PDA Task Force on virus filters and is Co-Chair of the ASTM subcommittee on Adventitious Agents for Tissue Engineered Medical Products.
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Gail Sofer
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