De-Risking Continuous Manufacturing from Clone Selection to Commercial Scale

Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.

The business case for regulated AI turns on the cost of producing an outcome that the quality system can accept.

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.

Structural modifications can improve peptide stability, solubility, and absorption to enable effective oral delivery.

The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.

Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.

Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.