06.28.22 -- Regulatory Changes And Impact To Biosafety Testing: What You Should Know

ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We discuss the expected changes and potential impact on viral safety strategies.

As with any known or new/emerging viruses, a comprehensive testing strategy is required to address the risk of adventitious viruses through the production process. We review currently available literature, our recommended SARS-CoV-2 virus detection test methods, and susceptibility of common biological host cells to infection.

Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. We explore risk areas in executing viral clearance studies and how to avoid them in designing viral clearance studies. Learn how to troubleshoot insufficient clearance issues and manufacturing deviations that impact viral safety.

Monoclonal antibodies are a rapidly expanding sector. These drugs are complex in their structure and their mode of actions. Gain an understanding of how an antibody’s molecular structure and its many measurable properties influences its binding and affects potency of a therapeutic biologic.