Designing Viral Clearance Studies for Biopharmaceuticals

This Designing Viral Clearance training discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing.

This presentation will discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing parameters. Other key topics will include the importance of addressing viral safety during process development as well as validation of the scale-down model. In addition to a good theoretical background, this presentation will also provide practical information and data from real studies.

What Attendees will Learn:

• Regulatory guidelines and their rationales
• Process development with virus clearance in mind
• Including mechanistically distinct steps for virus clearance
• Validating the robustness of virus clearance and generic validations
• Virus safety with respect to novel viruses
• Determination of viral reduction factors for the process
• Virus clearance expectations for early- and late-stage clinical trials
• Who Will Benefit
• This presentation will benefit biopharmaceutical professionals, managers and scientists involved in the following areas:
• Biotech Research & Development
• Process Development
• Manufacturing
• QC & QA
• Process Validation
• Regulatory Affairs
• Biopharmaceutical Consultants
• Outsourcing Professionals