AM25-TU-18-L - Why, When and How Should You Use Electronic Batch Records (EBRs) in the Cell and Gene Therapy Manufacturing Process

Proposed Session Description: Successful development and manufacturing of cell and gene therapies relies on the ability to generate reliable, documented, accessible data for the qualification of starting materials through the manufacturing activities. Failure to generate such data often leads to costly rework, delayed regulatory filings, and data integrity challenges that ultimately could slow or prevent regulatory approval of a therapy. Some fundamental tenets of data quality that are required by international regulatory agencies include legibility, timeliness, accuracy, completeness and availability. Adopting digital tools to address these tenets is paramount for efficiency and compliance. One such tool for building quality in the qualification of starting materials through the manufacturing of cell and gene therapies is the electronic batch record (EBR) system. This session will cover regulatory requirements for data integrity related to the development and production of cell and gene therapies whether part of donor screening, qualification of starting material, monitoring of manufacturing processes or qualification of a final product. It will also cover the role, implementation, and use of EBRs in the qualification of starting material and manufacturing of cell and gene therapies. Topics covered will include importance of data integrity, key data integrity principles (ALCOA+), best practices for implementing EBRs while ensuring data integrity, and compliance challenges specific to utilizing EBRs for the manufacturing process of cell and gene therapies.