All manufacturers of biologics are required to assess the ability of the manufacturing process to generate a product safe for human use. Therefore, a viral clearance study is performed to evaluate each step of the manufacturing process to ensure that it is effective at removing or inactivating viruses.

We have extensive experience in the design and performance of viral clearance studies, including TSE, for a wide range of different products.We take a customized approach that includes advice and regulatory support in the selection of process steps and model viruses, scaling-down of purification processes and subsequent design of study protocols to ensure a successful program is established and reported to meet your timelines.