When developing a tablet or capsule formulation, three widely used technologies are often considered to produce solid dosage forms: direct compression, wet granulation and dry granulation (including roller compaction). This article discusses why roller compaction is a robust option.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.