Crystallization inhibitors maintain super saturation of free drug during the absorption window upon oral administration. Formulators can achieve this by utilizing function excipients which provide solubilization enhancement and crystallization inhibition. We recently used the inhibitors to limit precipitation of drugs during the lipolysis of SEDDS and correlated with the Vivo performance. Additionally, these functional inhibitors effectively increased drug load and improved overall bioavailability by forming supersaturated-SEDDS. This podcast will cover the role of crystallization inhibitors in formulation and how to use in SEDDS formulation effetely.
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.