BioPharm International, November-December 2024

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.

Synthesis of DNA via cell-free methods has many benefits versus fermentation.

Many factors must be considered to overcome the challenges associated with viral clearance.

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

The 340B program is under greater scrutiny with more transparency for drug access being demanded by industry.

All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.