Using platform viral clearance data across multiple cell culture products Using Platform Viral Clearance Data Across Multiple Cell Culture Products Viral clearance studies are crucial components of the biopharmaceutical development process, particularly for cell culture-derived products such as monoclonal antibodies (mAbs) and vaccines. Regulatory expectations from agencies such as the FDA, EMA, and MHRA necessitate rigorous assessments to demonstrate that potential viral contaminants are effectively removed or inactivated during the manufacturing process. This article serves as a regulatory explainer manual, detailing the relevant guidelines, regulations, and agency expectations regarding the use of platform viral clearance data across related products. Context…

Bridging Viral Clearance Studies After Cell Line Change or Media Change in Biologics Programs Bridging Viral Clearance Studies After Cell Line Change or Media Change in Biologics Programs Viral clearance is a critical component in ensuring the safety and efficacy of biological products, particularly monoclonal antibodies (mAbs) and vaccines. When significant changes occur in the manufacturing process, such as a cell line change or a media change, companies must navigate complex regulatory requirements to demonstrate continued compliance. This article aims to provide Kharma and regulatory professionals with a comprehensive understanding of the regulations and guidelines surrounding viral clearance studies for…