The EFPIA Biomanufacturing Working Group is a cross-company industry team working to aid the development of biological products for patients. Through areas of special interests, the group supports and develops cutting edge science and technology strategies. In the first half the session the Working Group will show showcase some of the current concept papers under development.

In the second half of the session, presentations on the conversion of IV to SubQ Application will explore this key topic for the biomanufacturing community, with consideration of the challenges and opportunities it presents such as CMC device & formulation and bioavailability considerations, immunogenicity, modelling, and patient centric approaches to bridging, followed by a panel discussion.

Session Speakers - Concept Paper 2022 Updates:
Industry Perspective on Polysorbate Degradation and Control Strategies for Biopharmaceutical Products
Klaus Wüchner, Janssen Pharmaceutical R&D, Switzerland

Establishing a Platform Master Files Approach for Human Medicinal Products in the EU/EEA
Mihai Bilanin, GSK, Belgium

Session Speakers - Conversion of IV to SubQ Application Scientific Session:
Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities
Beate Bittner, Roche Diagnostics GmbH, Germany

Immunogenicity (or Not) of Biologics in the Subcutaneous Space
Sathy Balu-Iyer, University of Buffalo, United States

Modelling of Subcutaneous Injection & Bioavailability to Bridge IV/SubQ
Joel Gresham and Max Dixon, Crux, United Kingdom

SubQ Bioavailability Considerations
Manuel Sanchez-Felix, Novartis Institutes for BioMedical Research, United States

CMC Aspects When Switching from IV to SubQ Formulations
Christian Mayer, AGES MEA, Austria

Klaus Wüchner

Appearances