BioPharm International, November 2022

Increasing molecular diversity is creating a need for the reinvention of process development and control strategies.

A thorough knowledge of both the upstream and downstream processes is required to ensure effective removal of residual impurities in biopharmaceuticals.

Pharma companies set goals and adopt more sustainable alternatives.

Learning from early market failures, the biopharma industry has worked to improve the fate of antibody drug conjugates.

Experts reveal how to identify the “right” biochemical, the process of sourcing biochemicals, sourcing challenges, and what industry professionals should know about the space.

Industry experts discuss best practices for certificates of analysis.

In this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.

Various advances in contamination control are being utilized to reduce the chance pollutants contaminate a drug product.

FDA keeps its user fees but fails to gain important reforms.

Content is king in publishing, but interpretation is imperator.

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

Next year's "FDA Voices" series will cover core topics FDA staff are prioritizing.