Gene Therapy Production Must Pass Regulatory Hurdles
Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.
While researchers are succeeding with developing cell therapies and gene therapies, bringing technologies and processes to mass-produce the treatments, in an emerging and regulated environment, presents the biopharma industry with a unique set of challenges, says Eric Langer, managing partner, BioPlan Associates, in an interview with BioPharm International.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
