CMC Strategy Forum North America
Join us in-person in Washington D.C. at the CMC Strategy Forum where Just – Evotec Biologics will be participating in a workshop.
Who’s Attending
- Magnus Schroeder, VP Process & Product Design at Just – Evotec Biologics
Workshop Session 2 | Wednesday, 25 January at 3:15pm EST
One Site to Rule Them All vs the Multiverse of Sites – Will Distributed Drug Supply Strategies Introduce a Paradigm Shift for Biologics?
The conventional approach for manufacturing of therapeutic proteins has been to use a centralized paradigm with large-scale stainless-steel based facilities to enable material supply and manage cost of goods through the economy of scale. However, these conventional commercial biologics GMP facilities require significant capital investment, have long build times, and can necessitate large capital investments decisions early in the project lifecycle, where uncertainties about the launch and peak demands are still high and the biological assets are not yet fully de-risked. In addition, from an overall risk perspective as well as global vs local supply chain considerations, centralized manufacturing strategies are not without challenges.
Innovations such as high productivity cell lines, high titer media/ feeds, and high-capacity resins together with intensified process designs such as cell culture perfusion as well as continuous and connected downstream processes have enabled a significant increase in facility throughput. These innovations, coupled with the rise of single-use equipment and modular design GMP facilities, have brought the potential of commercial multi-ton capacities for protein biotherapeutics from small footprint production plants that can be rapidly built and replicated globally into reality enabling a distributed manufacturing paradigm. However, a shift to a distributed paradigm brings new challenges. Let us discuss the potential drivers for localization of DS/DP manufacturing to strategic markets and how to manage drug supplies from a distributed supply chain model with multiple replicate facilities.
Workshop co-lead by Magnus Schroeder at Just-Evotec Biologics, Riley Myers at CDER, FDA and Graham Tulloch at Jassen Research & Development
Speaker
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Magnus SchroederVP Process and Product DesignMagnus Schroeder joined Just-Evotec Biologics in August 2021 as VP Process and Product Design. He is leading the P&PD team at the Redmond JPOD site facilitating FIH, commercialization and technology development, and evaluation projects. Magnus has over 18 years of industry experience in early to late phase process development, CMC strategy, global tech transfer and technology development in the biopharmaceutical industry. Prior to joining Just, he held roles of increasing responsibility at Dynavax Technologies, Inc., CSL Limited, AGC Biologics and Avid Bioservices, Inc.. Magnus has supported the commercial launch of five biopharmaceuticals, a number of commercial processes and numerous IND/IMPD enabling development programs.
Magnus has received his M.S. in Molecular Biotechnology with a focus on mammalian cell culture from the University Bielefeld, Germany and earned his Ph.D. from the Research Center Juelich and University Bielefeld, Germany with a focus on protein purification development. He also conducted post-graduate research at the University of Minnesota and Rensselaer Polytechnic Institute in biochemical engineering and Deakin University, Melbourne, Australia in corporate management.