This article summarizes a discussion at LSX Biopharm America on September 11. A panel of industry experts discussed approaches to overcoming the most urgent CMC challenges during the discussion. The ...

FDA announces CMC review pilot for drugs with expedited development The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development ...

Developing a new medication can cost over $1 billion, depending on the drug’s complexity and expenses accrued via unsuccessful studies. Considering these costs, an optimized regulatory process is ...

Digital CMC offers significant opportunities for the pharmaceutical and biotech industries to enhance operational efficiency, improve regulatory compliance, and speed up time-to-market. By adopting ...

FDA wants participants for CMC readiness pilot for expedited drugs The US Food and Drug Administration (FDA) announced on 11 September a limited chemistry, manufacturing and controls (CMC) development ...

Dr. Olga Paley, Director of Bioprocess Development at Takeda, will discuss “Advancing Takeda’s Bioprocessing Platforms in Support of Clinical and Commercial Drug Supply” about the Chemistry, ...

This webinar explores an integrated approach to mAb development that embeds manufacturability, scalability, lifecycle ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

LUND, SE / ACCESS Newswire / March 10, 2026 / Spago Nanomedical AB (publ)(STO:SPAGO.ST)(FRA:7UX.F) announced today that Torsten Malmström has assumed the position of Director CMC & Supply. Torsten ...

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...