Dr. Rümenapp is based in Wuppertal, Germany and working within the Product Supply Biotech organization of Bayer AG, where he is responsible for the transfer of Bayer’s pipeline candidates (antibodies and antibody-drug-conjugates) to external manufacturing partners and regulatory submission and launch preparations.

Prior to working in Development, Dr. Rümenapp was Head of Biotech Projects in Product Supply Biotech at Bayer, where he was responsible for contract manufacturing partnerships in the field of biotechnological drug substances and drug products and interdisciplinary project management with the goal to ensure market supply. Before it was acquired by Bayer, Dr. Rümenapp hold a similar position at Schering AG, and before that, he worked in the Production & Logistics department of Schering, where he was responsible for production aspects of in- and out-licensing deals, due diligences, and product acquisitions of small molecule products and biologics. Dr. Rümenapp studied chemistry and holds a Ph.D. in biosciences. He worked several years in academic research in the field of signal transduction and as an assistant teacher in the field of general pharmacology. Today, Dr. Rümenapp area of expertise is the set-up and management of external relationships for the development and supply of bio-pharmaceutical products. He has more than 20 years of experience in the bio-pharmaceutical industry.To correspond with Dr. Rümenapp, please contact him at [email protected].

Presentation Title: In-house Manufacture or External Sourcing of Gene Editing Reagents to Support the Growing Cell and Gene Therapy Business

Abstract: Beyond small molecule drugs and classical biopharmaceuticals like antibodies, cell and gene therapies are becoming more and more important to treat patients with severe diseases. Genome editing holds a great promise for cell-based therapies. Reliable manufacture and supply of the reagents used for gene editing - in the necessary quality - is essential. Depending on the application, gene editing reagents (GERs) may be starting materials or drug substances to be made following GMP principles or under full GMP. For development, clinical and commercial manufacture, companies need to decide between building internal capabilities, esp. for process development and production, or external sourcing. The presentation will review the approaches and benefits and challenges for the supply of GERs, from in-house or external suppliers.

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