BioPharm International April 2025

Hurdles exist across all aspects and phases of drug development and manufacturing.

This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.

Wider adoption of single-use technologies and systems is aligning with sustainability goals for the industry.

Process consistency and robustness, analytical excellence, and regulatory compliance are essential in the scale-up of biosimilars.

More and more contract manufacturers have been looking not at what the state of the supply chain is right now, but what it may be in the next three to five years.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players.