ATMP Group Developments from January to April 2025

Board Development & Resolutions
Dr Roland Pach joined the Board. He is currently Global Expert Cell & Gene Therapy Analytics CMC at Roche. His many years of expertise will support the Group's Board in many tasks and decisions.

Guideline Developments
Pharmaceutical products regulated by national competent authorities and international guidances like those from ICH follow the concept of a medicinal product manufactured in an industrialized setting. Guidelines are based on the understanding that all materials and processes used can be well controlled. Specifications as a set of attributes, the methods to asses them and related acceptance criteria define the material attributes, process steps and product quality. This concept works well for materials that are derived from controllable processes. However, some starting materials come with an inherently high variability. For this reason, the ECA ATMP Interest Group has prepared a position paper on the Recommendation on patient-centric specifications for ATMPs. The paper is scheduled to be published in September 2025.