ICH: New Recommendations for the Manufacture of ATMPs
The ICH’s Cell and Gene Therapy Discussion Group (CGTDG), which was established in May 2023, has provided recommendations with regard to future Advanced Therapy Medicinal Products (ATMPs) Related Guidelines.
Regarding the manufacture of ATMPs, a central proposal is the development of an Annex to ICH Q11, specifically addressing the unique challenges of ATMP process development, material control, and control strategies
The CGTDG highlights that conventional manufacturing and validation approaches are often difficult to apply to ATMPs due to inherent variability in starting materials, limited batch sizes, and constraints in analytical testing. The proposed annex would therefore promote risk-based and flexible development approaches, including the use of platform technologies and alternative validation strategies where standard methods are not feasible.
Key focus areas include clearer and more harmonised expectations for starting and raw materials, particularly those of human or animal origin, with emphasis on quality criteria, viral safety, traceability, and transportation. In addition, the recommendations stress the need for an ATMP-specific control strategy, acknowledging variability in autologous and other complex products and addressing the management of out-of-specification batches where justified by patient benefit.
Source:
ICH: News
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