Panelists:
Nicholas Brown
Senior Laboratory Technician
Charles River Laboratories
Panelist
Nicholas Brown
Brown joined Charles River in November 2022 after completing his bachelor’s degree from the University of Scranton. Brown started his journey in the Viral Clearance Department at the Wayne, PA site as Laboratory Technician 1. His background includes both chromatography and virus retentive filtration. He also works as a study lead within the team to assist with client study management and execution.
Janalyn Frederick
Supervisor, Process Evaluation
Charles River Laboratories
Panelist
Janalyn Frederick
Frederick joined Charles River in July 2016 after completing her bachelor’s degree from DeSales University. Frederick started out at the King of Prussia Viral Clearance site as Technician 1 and was involved in the site transfer to the Wayne, PA facility. Her background includes virus propagation for the department and virus retentive filtration. She has also worked as an associate scientist within the team, running client studies and maintaining internal lab work. Now as a supervisor, she manages direct reports and client studies.
Broadcast Date:
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Recent revisions to the Food and Drug Administration’s ICH Q5A guidelines are driving a renewed focus on virus titer and purity during viral clearance testing for therapeutic proteins. The updates reinforce the need for virus stocks with verified titer, purity, and reproducibility, while expanding the scientific basis for viral clearance validation. Specifically, Q5A (R2) encourages the use of next-generation sequencing and other molecular methods to supplement or replace traditional assays as well as calls for deeper characterization of viral inactivation among other updates. And the changes are reshaping how viral clearance studies are designed and evaluated.
In this GEN webinar, our expert speakers will share emerging methods and strategies in virus production and characterization that help manufacturers align with regulatory expectations. Key takeaways will include:
- How small-scale, closed-system bioreactors streamline virus production and improve study efficiency.
- How new virus production and purification practices align with the Q5A (R2) expectations
- How virus purity can influence filter performance and viral clearance robustness in viral clearance studies
A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelists.
Produced with support from:
