Risk Mitigation and Management to ensure Virus Safety of Biopharmaceuticals: Regulatory Perspectives and Industry Best Practices

Patient safety is at the core of biopharmaceutical manufacturing operations. Ensuring virus safety of biopharmaceutical products poses logistical challenges for several reasons including: nature of raw materials, non-homogenous distribution of raw materials, and limitations with virus detection methods.
This webinar will address the regulatory basics in virus safety assurance, the need for incorporation of multiple orthogonal virus clearance strategies, and design of validation studies. Case studies will be presented to demonstrate industry best practices. In addition to risk management in downstream operations, the importance of risk mitigation in upstream operations to minimize bioreactor contamination events will be discussed.

Learning Objective 1:  Learn about the  regulatory basics in virus safety assurance of biopharmaceutical products.

Learning Objective 2:  Learn about common virus clearance technologies used in the biopharmaceutical industry.