All drugs approved in the US marketplace went through an extensive, multi- million dollars, multi-year journey before being available to patients. In order to bring a new drug to the market place requires extensive resources, technical acumen, and an unbendable commitment to the goal. CDMOs are alongside pharma companies helping them navigate the process and mitigate risk. By choosing the right partnerships, you can give your drug production the competitive advantage it brings to the marketplace. Listen to Soojin Han, Director of the CLD group at Samsung Biologics, as she talks about what is the CDMO partnership and how Samsung Biologics can help many scientists for drug development to speed up the drug product to the marketplace and support many people's health life.
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.