Explore analytical approaches to innovative cell and gene therapies at the annual USP Biologics Stakeholder Forum. Each year, industry, regulatory, and scientific experts gather to discuss pressing challenges at the interface of biotherapeutic quality and innovation. USP, an independent, nonprofit, science- and mission-driven standards development organization, gathers and explores the ideas from the forum to develop impactful quality standards that help ensure access to safe and efficacious medicines.
This year’s forum will focus on the analytical challenges associated with cell and gene therapy products, including shortened development timelines due to accelerated regulatory review, small production batches, and in some cases, short shelf lives. Sessions will explore analytical innovations that efficiently and cost-effectively support process and product understanding, process validation, and product release.
- The morning session features USP, FDA, and industry speakers, followed by a discussion of new and innovative analytical approaches.
- The afternoon session features speakers and discussions that focus on the application and validation of NGS-based techniques.