Maintaining GxP with a 21 CFR Part 11-Compliant Tracking System

The acquisition boosts BioNTech’s mRNA design and manufacturing capabilities, accelerating development of next-gen cancer immunotherapies.

In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.

The agreement has been designed to offer a turnkey service to companies seeking faster time to market.

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

NMPA’s Center for Drug Evaluation accepted Merck KGaA’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with TGCTs that require systemic treatment.

The quickly evolving development of biopharmaceuticals is impacting innovation in the industry overall.