ORC International’s report Implications of Inaccurate Forecasting on Biologics Drug Substance Manufacturing explores causes, consequences, and potential solutions to forecasting challenges related to biopharmaceutical drug substance manufacturing. It provides insight and perspective on key themes that emerge from the report, offering additional solutions to prepare for inevitable forecast inaccuracies.
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.