In this Weekly Supplement, IPQ highlights the emphasis FDA is placing on a risk-based control strategy approach to assuring potency for CGTs that is aligned with ICH Q8-14 principles and similar in scope to the multifaceted expectations for assuring sterility. In focus is a discussion by CBER Division of Gene Therapy 1 Director Andrew Byrnes at the June CASSS CGT Symposium of how this potency assurance approach was built into the recent revamping of FDA’s 2011 guidance on CGT potency testing and why this broader control strategy is essential in the CGT CMC context.
Along with a feature story on a presentation given at a recently held conference by a leading regulator that addresses the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.
Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.
Appended to the issue is a chronological listing of the headlines of the in-depth stories that IPQ has released since 2020. Readers of the Weekly Supplement are invited to click through to those that are of particular relevance to the regulatory presentation, news briefs, or compliance developments provided in the issue. Those of especially high relevance to the featured regulator story are indicated with a red star.
