@JB1975 It appears Matt Klinker has a degree of flexibility.
At the closing of 2023, the FDA released a new guidance document, entitled “Potency Assurance for Cellular and Gene Therapy Products” (2). This is immediate and essential reading for all stakeholders in the CGT field. In keeping with the rapid advancement of cell therapies in recent years, the FDA’s intention is to guide effective product potency assurance that is at the same time constructive, feasible and flexible, yet stringent at its core principles. A great starting point for learning about this new guidance is provided by a publicly available 20 min pre-recorder webinar (3). Matthew Klinker, FDA’s Office of Therapeutic Products (OTP), provides a high-level introduction of the new “broad approach to assuring potency”, defined as the Potency Assurance Strategy (PAS). PAS applies to all stages of the product development lifecycle. Although manufacturing protocols are the fundaments to production of consistent product lots, measured by in-process in release testing, the scope of the PAS goes beyond manufacturing alone.
This new 2023 draft guideline for potency assurance provides a very useful and timely framework. Where the earlier guidance published in 2011 mainly focussed on potency tests, the 2023 document describes a broader approach, that can be flexible as needed, but remains stringent on core measures, such as definition of acceptable ranges for potency measures and weighing the relevance of data output from different measures. Who’d have “thunk” using FDA and flexibility in the same sentence a few decades ago? Here FDA appears true to its ambition of seeking to be conceptual and enabling of innovation in the world of the complex and ever evolving therapeutic modalities that CGT products comprise.
I will have more to say on potency test a bit later. In this Webinar
the last aspect of an effective potency assurance strategy i'll discuss today is that it should get better over time, as you learn more about your product and your manufacturing
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(20min delay)