As Continuous Manufacturing Approaches 'Tipping Point,' Successful Applicants Share Tips

27 Jun 2018

• By Joanne S. Eglovitch

The pharmaceutical industry may be approaching a "tipping point" with applications for continuous manufacturing, and successful applicants share secrets to the success they have achieved with FDA and other regulatory authorities around the world.

As growing interactions with FDA signal a surge in applications for continuous manufacturing of pharmaceuticals, early adopters of this technological alternative to traditional batch processing are advising the next wave of applicants to meet early and often with the agency.

The status of continuous manufacturing as well as some strategies for getting applications approved worldwide were discussed June 7 at...