AGC Biologics

Process validation is essential in biopharmaceutical drug production to ensure product consistency, safety, and quality at every clinical stage, and to effectively reach commercial approval. It minimizes risks, reduces costs, and facilitates a smoother transition from earlier clinical stages to large-scale production, ensuring that drugs are made efficiently safe and effective for patients.

Christoph Winterhalter, Chief Business Officer of AGC Biologics, highlights trends in single-use technology, the CDMO’s new fill-finish capabilities, facility expansions, the potential impact of the U.S. Biosecure Act, and the growing cell and gene market.

Robust, scalable manufacturing of novel therapeutics requires partnering with a CDMO equipped to adapt to changes in the market and knowledgeable on the latest technologies used to support cell line development.

Robust, scalable manufacturing of novel therapeutics requires partnering with a CDMO equipped to adapt to changes in the market and knowledgeable on the latest technologies used to support cell line development.

This research outlines recent changes in the monoclonal antibody market, the great potential for pathogen-focused mAb treatments and important industry factors impacting how to antibody products can navigate through clinical stages.