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.
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.
The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
