This Viral Safety webinar training will discuss the testing used to generate data for risk assessment and train how to calculate viral risk.
Learning objectives :
- How do I know if the viral clearance my process provides is enough?
- Retrovirus or Retroviral like particles are present in my production cell line. How does this impact my downstream process?
- How do I calculate viral risk?
Why should you Attend:
An inherent risk exists for biotechnology products derived from cell lines. To date these products have not been implicated in the transmission of viruses, but the risk is still present, and the clinical consequences of a contamination event are potentially very serious. Consequently, manufacturers are expected to provide a level of confidence that their product has a very low risk of virus transmission. This is done by preparing a risk assessment in which the risk of transmission of a known viral pathogen is calculated. The risk assessment incorporates data from three sources: 1) testing product source materials such as cell lines and raw materials for adventitious viruses, 2) verifying the absence of viral contaminants in process intermediates and 3) demonstrating the capacity of the manufacturing process to clear infectious viruses.
This presentation will explain the testing used to generate data used in the risk assessment and walk attendees through the calculations using several examples.Please have a scientific calculator handy and re-familiarize yourself with the "log" and "anti-log" (10x) functions.
Areas Covered in the seminar:
- The viral testing required for source materials.
- Determine if there is enough viral clearance for your process .
- How the testing for adventitious viruses is related to viral clearance.
- How to calculate a risk factor.
- Which stage(s) of development require risk assessments.
Who will benefit:
This webinar will provide valuable assistance to all biopharmaceutical companies that produce biological products from cell lines. Companies that manufacture human- or animal-derived products will also find this information useful. The employees who will benefit include:
- Process development scientists
- QA managers and personnel
- Regulatory personnel
- Consultants
Instructor Profile:
Kathryn Martin Remington, Ph.D. is the Senior Manager of Virology at Catalent Pharma Solutions, in Research Triangle Park, North Carolina, a full-service solution provider to the pharmaceutical industry. She holds M.S. and Ph.D. degrees in Microbiology and has over 20 years of experience in virology. Before coming to industry, she worked in research studying drug resistant AIDS viruses. She was previously the Section Head of Viral Validation for Bayer HealthCare. Kathryn has been involved in the viral safety of biologics for over 12 years and is the author of number scientific publications on viral safety. She is a frequent speaker at conferences and workshops.
