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.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.
Boyang Wang, Immortal Dragons, explains how FDA’s Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China’s 818 Decree.
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.
