Evaluating how much a process step contributes to viral clearance is an essential part of process validation. For this reason, there is an industry need to perform effective viral clearance studies. 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.
May 9, 2019
Case Study: Virus Reduction of an Affinity Capture Step
Evaluating how much a process step contributes to viral clearance is an essential part of process validation. For this reason, there is an industry need to perform effective viral clearance studies. 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.