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

The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.

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.

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

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.

Trump’s tax bill could reshape drug R&D, manufacturing, Medicaid access, clinical trials, and biotech funding, impacting strategy across the bio/pharmaceutical industry.

Eli 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.