Modern drug development faces a two-part pressure test: molecules are getting harder to formulate, and global manufacturing routes are getting harder to rely on. Poor water solubility and limited physical stability continue to delay many small-molecule and peptide programs, while shifting trade policies, logistics constraints, and onshoring pressure increase the cost and risk of fragmented supply chains. Sponsors need formulation strategies that improve performance and also translate cleanly to robust, predictable manufacturing. This paper explores how integrating large-scale domestic spray drying capacity earlier in development can accelerate timelines, lower costs, and strengthen portfolio resilience in an unpredictable global landscape. It outlines how this approach supports rapid development, enhances cost efficiency for high-volume therapies, and mitigates risks tied to international manufacturing disruptions.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.
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.