Session Details

Speakers, titles, times, and locations of ASGCT presentations

Detailed Program

Enabling Analytics for Decentralized and Point-of-Care Manufacturing (Organized by the CMC Committee)

There has been significant discussion among CGT developers about the opportunities and challenges of alternative manufacturing models, especially decentralized and point of care approaches. One of the greatest challenges to make these models a reality, however, is determining how to perform analytics for product release. This session will focus on that aspect, offering a regulatory overview of the different manufacturing models, a deep dive into analytics and how to enable them, and lessons from companies that are working to put these models into action.

Session Details

Co-Chair

Co-Chair

Defining the Issues: FDA’s Approach to Centralized, Decentralized, and Point of Care Manufacturing for CGTs

The Importance of Analytics for CGT Manufacturing Models and How to Enable Them

Enabling distributive point-of-care manufacturing of CAR-T and other gene-modified cell therapies within an academic medical center network

What are Regulatory Expectations for Analytical Testing of Bedside Cell Therapies: The Lupagen Experience Across Several Jurisdictions

Panelist

Panelist

Panelist

Panelist

This site uses cookies to offer you a better user experience and to analyze site traffic. By continuing to use this website, you accept our use of cookies.