Selection and Detection of Viruses in Viral Clearance Studies
Instructor:
Kathryn Martin Remington
Product ID: 700824
- Duration: 60 Min
Data from viral clearance studies are used to assure the viral safety of the manufacturing process for a biopharmaceutical and are required for IND and BLA submissions. Whether your viral clearance studies are performed in-house or at a contract lab, it is important to be able to understand which viruses should be used in the viral clearance study, the assays that are used to detect them and to critically evaluate your viral clearance data. In this webinar you will learn the guidelines for selection of a virus panel. You will also learn about the infectivity and qPCR assays used to measure viruses and when it is appropriate to use each type of assay. You will learn how virus titers and log reduction values are calculated, so that you will be able to evaluate data from the virology laboratory.
Areas Covered in the seminar:
- What FDA and EU guidance documents expect for selection and detection of viruses?
- Selection of a viral panel for viral clearance studies.
- Appropriate virus panels for stage of process development.
- Virus infectivity assays.
- Use of qPCR for virus detection and when to use it.
- Calculation of virus titers.
- Calculation of log reduction values.
Who will benefit:
This webinar will provide valuable background for those who need to evaluate viral clearance data. The course will benefit individuals such as:
- Process Development Scientists
- Manufacturing
- QC & QA Scientists
- Research & Development
- Regulatory Affairs
- Consultants
Kathryn Martin Remington,Ph.D., is the Senior Manager of Virology at Catalent Pharma Solutions (formerly Cardinal Health) in Research Triangle Park, North Carolina, a full-service solution provider to the pharmaceutical industry. She has worked in research studying drug resistant AIDS viruses and was previously the Section Head of Viral Validation for Bayer HealthCare. Kathryn has over 20 years of experience in virology and has been involved in the viral safety of biologics for over 10 years. She is the author of number scientific publications on viral safety and is a frequent speaker at conferences and workshops.
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