Understanding and Implementing a Risk-Based Approach to 21 CFR Part 11 Compliance

7-OH and the leaf of the kratom plant are not analogous, but as the former is a derivative of the latter, it has opioid-like qualities that make its susceptibility to abuse concerning.

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.

FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and help prevent drug shortages.

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.

Modular process design, single-use technologies, and flexible filling lines are some of the ways manufacturers can combat challenges involved in small-batch manufacturing.

Re-Vana’s drug delivery technology is designed to release treatments over a 6- to 12-month period, with the goal of reducing frequency of injections for patients.