As increasingly complex, poorly water-soluble molecules enter development, AustinPx helps developers look beyond near-term needs and select the right ASD technology for the full program. With spray drying, hot-melt extrusion, and KinetiSol™ under one roof, our team evaluates leading ASD approaches early and, on a drug-specific basis. Through comprehensive screening, optimization, biopharmaceutical analysis, and early manufacturing assessment, we help clients identify the right formulation and process before late-stage commitments are made, reducing the risk of reformulation, clinical delays, PK bridging studies, manufacturing constraints, and rising cost of goods while protecting scalability, patient experience, and long-term asset value.
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.