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
Instructor Profile
Kathryn Martin Remington Ph.D. is the Senior Manager of Virology at Cardinal Health in Research Triangle Park, North Carolina, a full-service solution provider to the pharmaceutical industry. Kathryn has over 20 years of experience in virology and has been involved in the viral safety of biologics for over 10 years. She has experience with both recombinant and human blood and plasma-derived products. She is the author of number scientific publications on viral safety and is a frequent speaker at conferences and workshops.
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