Advanced Therapy Medicinal Products (ATMP) Guidance and Supplementary Chapter for Analytical Quality by Design (AQbD)
We have published new guidance in the BP 2022 to support users in applying and developing analytical methods.
Advanced Therapy Medicinal Products Guidance: Application of Flow Cytometry
ATMPs provide an unprecedented opportunity to manage or treat diseases. Their success is underpinned by the implementation of suitable characterisation techniques for assessing their Quality.
Here at the BP we have engaged with groups across the ATMP community to develop non-mandatory guidance for key analytical technologies to ensure product quality, safety, and efficacy throughout the entire product lifecycle.
The first guidance is related to the application of flow cytometry and is written by experts in flow cytometry for the ATMP community.
Available to all users on the BP2022 online Advanced Therapy Medicinal Products Guidance
Supplementary Chapter X: Analytical Quality by Design concepts for analytical procedures
Responses to the BP’s public consultation in 2019 underscored the importance of AQbD concepts as potentially transformative catalysts for enabling innovation for analytical methods and ultimately further supporting the assurance of medicines quality. The result of the consultation has been the adoption of a strategy and accompanying work programme that will continue to drive forward this important area of regulatory science.
The first outcome of this work programme, the “Supplementary Chapter on the use of Analytical Quality by Design concepts for analytical procedures”, was published in the BP 2022. The non-mandatory guidance this Supplementary Chapter provides will support users in the application of Analytical Quality by Design principles to pharmacopoeial procedures and across the entire Analytical Method Lifecycle.
Available to all users of the BP2022 online and hardcopy products SC X: Supplementary Chapter on the use of Analytical Quality by Design concepts for analytical procedures