In this revised draft, FDA gives a substantial facelift to its original 2011 guideline on Potency assays for Cell and Gene Therapies.
It introduces a holistic "Potency assurance strategy" that encompasses a thorough understanding of the product MOA, QTPP and "Potency-related" CQAs (because in these therapies- potency is achieved by a combination of factors usually).
It emphasizes the big picture of process understanding and a risk-based control strategy and makes several references to Quality Risk Management and Knowledge management.
This is the mindset of QBD and shows how the industry has matured since the early days after ICH Q8 was introduced.
The original guideline was still largely focused on final product testing, which is very challenging to rely on in cell therapies.
We learned over the years how to apply design thinking and leverage its principles to gain more operational flexibility, and this approach comes to shine in the complex realms of Cell and gene therapies, where QBD is a must-have.
Download the guideline here
and if you want a short overview, from FDA directly, check out this webinar.