Scaling production of mAb drugs remains a critical industry challenge – especially in downstream process chromatography steps. This Avantor White Paper details how technologies such as a novel protein A chromatography resin and the use of additives can improve efficiencies in this complex process step. It also reveals the potential for expanding single-use and continuous processing systems to help further streamline downstream production and improve cost profiles.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical industry and how CPHI Milan is addressing these areas this year.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.