Revised ISO Cleanroom Standards Improve Air Cleanliness Classification

Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.

Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.

Sanjay Konagurthu, PhD, senior director of Science and Innovation at Thermo Fisher Scientific, explains what teams need to do to ensure the usefulness of AI and what strides have been made with AI in regulatory submissions.

This week on PharmTech.com, experts discussed E&L suitability standards, rare disease treatment development, sourcing ingredient suppliers, the use of AI in quality control, and more.

How to test pen injector assembly interfaces from URS to FAT and SAT: verify part tracking, reject confirmation, restarts, and data transfer evidence.

FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.

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.

FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.