Manufacturers Face Challenges and Regulatory Changes

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

Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.

Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.

Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.

Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.

FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.

Mahmood Majeed, ZS, explains why measurable AI outcomes in pharma supply chain and manufacturing jumped from 29% to 53%, and how GMP limits and GxP validation shape adoption.

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