The biomanufacturing wing of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing & Quality Expert Group (MQEG) is heavily focused on how to gain more leverage from platform technologies, prior knowledge and risk-based tools in streamlining and harmonizing the regulatory expectations for assessing comparability, specification conformance, and lifecycle management for the expanding universe of biotech products.
The issues involved in adapting regulatory processes to make them more innovation supportive across the development and manufacturing spectrum for advanced biotech therapies and vaccines were in focus at the EFPIA satellite session that preceded the October 2025 CASSS Europe CMC Strategy Forum, held in Basel, Switzerland.
At the session, representatives from the biomanufacturing team provided status updates, shared data, and outlined emerging concepts and proposals from the team’s ongoing activities.
Roche EU CMC Regulatory Policy Head Markus Goese opened the session with an overview of EFPIA’s role, structure, and current biomanufacturing and quality priorities. Five presentations followed, addressing specific pressure points in contemporary practice and providing a snapshot of selected areas of current focus within the EFPIA biomanufacturing program:
● Novartis Global Biologics & CGT Science & Technology Director Karoline Bechtold-Peters presented findings from a recent EFPIA member survey on current trends in antibody-drug conjugate (ADC) development.
● GSK Vaccines Discovery and Development Global Regulatory Lead Mihai Bilanin provided an overview of prior and platform knowledge use in the EU and how to increase regulatory support through a master file approach.
● UCB Pharma Group Lead Cyrille Chéry provided an update on the EFPIA polysorbate working group – presenting recent industry-wide findings on polysorbate degradation and the implications for product quality and safety.
● Amgen Global Regulatory Affairs CMC team member Andrew Lennard outlined the “sister sites” concept – a risk-based approach for streamlining technology transfers to new manufacturing sites.
● Bechtold-Peters then returned to the podium to provide an update on EFPIA’s work on advancing subcutaneous formulations.
The second part of the morning EFPIA session explored the CMC challenges of multispecific antibodies – including managing product- and process-related impurities, quality control and analytical methods, and the formulation – and the diverse design architectures and engineering strategies involved.
Speakers included Paul-Ehrlich-Institute’s Steffen Gross on the “challenges of multispecific antibodies from the reviewers perspective.” [For a review of the discussions on the CMC challenges and regulatory experience with bioconjugates and multispecifics that took place at the Summer 2025 CASSS CMC Strategy Forum in Gaithersburg, MD see IPQ’s August 29, 2025 Weekly Supplement and October 29, 2025 News in Depth.]
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