Subscribe
  
IPQ Inside the global regulatory dialogue

CBER Reviewers Are Working with Sponsors in Exploring CMC Flexibility for Cell and Gene Therapies

Sep 28th, 2019

Please Log in to print the full article

His first example was the potential for release of process performance qualification (PPQ) batches for distribution before completion of process validation. This type of flexibility, Oh commented, could be used to alleviate problems with limited...

You must be a paid subscriber to continue reading this article. If you are a paid subscriber, please Log in. If you are not a paid subscriber, please subscribe now.

©2019 IPQ Publications