The market momentum of novel therapies targeting unmet needs is creating a new landscape for pharmaceutical drug manufacturers. As the focus on these smaller patient pools grows, so does the complexity of drug development. Companies must understand how the molecules filling today’s pipeline are changing our business, as they are causing a dramatic shift in how we plan for and execute drug development and manufacturing.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
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.