Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.

Jason Bertola, executive director of Commercial Development for the Advanced Synthesis Platform at Lonza in North America, explains the demand for spray drying and the hurdles involved with scale up, in an interview with PharmTech.

Jane Zhang of ETCH Sourcing explains why geopolitics, transparency, and partnership now weigh as heavily as cost and quality when companies choose suppliers, in this episode of Ask the Expert, moderated by Susan J. Schniepp of Nelson Labs.

Jaenisch, Muraru, and Pandey discuss new skills for QC and regulatory teams, plus patient trust, as new approach methodologies reshape pharma.

Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.

Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.

Panelists on PharmTech AI Pulse Check debate SURPASS, a new digital-twin trial program, regulatory acceptance, and the data-cleanup burden it will create.

AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.