Delivering safe drugs is critical for biomanufacturers. Evaluating how much a process step contributes to viral clearance is therefore an essential part of process validation. For this reason, there is an industry need to perform effective viral clearance studies.
Scope of the viral clearance case study
In this study, the virus reduction of an affinity capture step was evaluated in a scale-down column format. The study was performed by a third-party viral testing laboratory in collaboration with a biopharmaceutical company.
- A robust process providing expected virus removal for different sample loads and residence times.
- Reduction factors were in the typical range for a protein A affinity chromatography step.
- The chromatography column format was well-suited for the viral clearance study.
Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.