Webinar Overview
Scaling up both manufacturing programs and processes of gene and gene-modified cell therapies in preparation for IND filing presents significant challenges, from transitioning through discovery and clinical phases to achieving GMP-compliant commercialization. Open systems, manual processes, and contamination risks often complicate the process, making early consideration of scalability essential to avoiding delays and costly adjustments.
In this webinar our experts will discuss the benefits of a full-funnel approach, which will help you meet regulatory requirements from the very beginning, as well as other key development considerations. Whether you’re starting from scratch or optimizing existing manufacturing processes, this webinar offers actionable tips to accelerate development while maintaining quality and confidence in your therapeutic.
Join to get a better understanding of:
- Current challenges in gene and gene-modified cell therapy manufacturing and how to overcome them
- Why it’s important to think about scalability early on in development
- Criteria for selecting a CDMO partner to assist in getting your therapeutic from research and discovery stages all the way through commercial manufacturing, seamlessly
Webinar Presenters
Alan Smith, PhD
Executive Director of Operations Excellence, Biomanufacturing
Charles River
Chris Perrin-Porzondek, BS
Director of Vector Manufacturing & Process Development
Charles River
Have a scheduling conflict? Sign up even if you can't make it; we'll share the recording after.