ComplianceOnline

Viral Safety of Biopharmaceuticals from Process Development to Licensure

Instructor: Kathryn Martin Remington
Product ID: 700516
  • Duration: 60 Min

recorded version

$149.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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Read Frequently Asked Questions

This Viral Safety webinar will provide case study examples that demonstrate the importance of pre-validation viral clearance data for optimizing a process step to provide robust viral clearance.

Demonstration of the capacity of a manufacturing process for robust viral clearance is an essential part of assuring the viral safety of a biopharmaceutical product. The scope of the viral clearance evaluation varies with the stage of product development. Data from viral clearance experiments that are performed early during development often facilitate process decisions, such as the choice of a nanofilter or establishing operating parameters. These studies can also provide information about the mechanism of viral inactivation or removal. As product development proceeds, the viral studies become more complex and are designed to provide information about the influence of small variations in processing parameters on viral clearance. This presentation will provide case study examples that demonstrate the importance of pre-validation viral clearance data for optimizing a process step to provide robust viral clearance. In addition study designs that are appropriate to support various stages of product development will be described. Finally, information about the small scale model and importance of the virus preparation used as a spike will be discussed, again drawing on data from real-life examples.

Areas Covered in the seminar:

  • Use of viral safety data to make process development decisions
  • Appropriate design of viral clearance studies to support various stages of process development
  • Evaluating the robustness of viral clearance
  • Impact of virus spike preparation on performance of small scale model

Who will benefit:

  • Process Development Scientists
  • Research & Development
  • Manufacturing
  • QC & QA
  • Process Validation

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. 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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