Abstract

Outsourcing partnerships for CMC development and manufacturing of biologics are of strategic importance for many companies esp. with innovative pipelines and employing new technologies. Antibody-drug conjugates (ADCs), linking small molecule highly potent drugs to antibodies for efficacy and targeting, offer new treatment options esp. in oncology, while the complexity of ADCs makes their CMC development and manufacturing challenging. Especially in determining its clinical as well as commercial manufacturing set-up, companies must consider what best suits their needs and decide between building internal capabilities and outsourcing. The presentation will review the benefits and challenges, best practices, and how to avoid pitfalls when producing in-house and/or outsourcing the manufacture of antibodies and ADCs to external partners. Right expertise and fruitful CDMO partnerships allow to avoid or overcome development, supply and quality issues, ultimately leading to timely launch readiness.

Biography

Dr. Rümenapp is based in Wuppertal, Germany and working within the Biological Development 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 15 years of experience in the bio-pharmaceutical industry.

To correspond with Dr. Rümenapp, please contact him at [email protected].

Company profile

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