Catalent’s recent completion of a $30 million (€27 million) project at its facility in Limoges, France, transformed the site into a European center of excellence for biopharmaceutical development, drug product fill/finish services, and packaging. The site further expand Catalent Biologics’ global network, with early phase integrated clinical development through to clinical supply services and small-scale commercial manufacturing, allowing seamless tech transfer of projects as they progress to late-stage and larger-scale commercial supply from other Catalent manufacturing facilities in Europe and North America.
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.