Viral Validation for Biopharmaceuticals
Instructor:
Kathryn Martin Remington
Product ID: 700187
- Duration: 60 Min
Ensuring the safety of the manufacturing process for a biopharmaceutical and meeting regulatory requirements can be complicated and costly.Understanding the rationale behind viral safety can help to make viral validation studies more than just a box to check on the way to licensure of a product. Viral safety should be considered throughout a manufacturing process, from source materials to setting processing limits. This presentation will provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation study. In addition to a good theoretical background, this presentation will also provide practical information and data from real studies.
What Attendees will Learn:
- Potential viral contaminants, including emergent viruses, and their risk
- Ensuring viral safety in source materials
- Regulatory guidelines and their rationales
- Conventional and innovative methods of virus inactivation and removal
- Assays to detect viruses in clearance studies and their advantages and disadvantages
- Appropriate virus spikes
- Including robustness viral clearance studies
Who Will Benefit:
This presentation will benefit biopharmaceutical professionals, managers and scientists involved in the following areas:
- Process Development Scientists
- Research & Development
- Manufacturing
- QC & QA
- Process Validation
Kathryn Martin Remington, Ph.D. is the Senior Manager of Virology at Cardinal Health in Research Triangle Park, North Carolina, a contract laboratory that performs biosafety testing and viral clearance studies for biopharmaceutical products. 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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