Scaling for Commercialization: Considerations for Large-Scale API Production

Bertram Cezanne heads process development synthesis within the electronics business of Merck. A chemist by training, he holds a Ph.D. in synthetic organic chemistry. In 1997, he joined Merck and worked for more than 15 years in drug discovery and early scale-up, where he gained broad experience in synthetic organic chemistry at different scales. Since 2016, he has been responsible for process development and supply of APIs, intermediates, and excipients during the development phase until launch and commercial manufacturing.

Bertram Barnickel heads the value stream management CDMO organization within the electronics business of {Hcompany}. He is responsible for technical feasibility studies and technical quotations during project preparation as well as for project management of CDMO projects during implementation. Bertram is an organic chemist by training and holds a Ph.D. in organic synthesis. He has more than 10 years of experience in process development, API manufacturing, and project management in the chemical and pharmaceutical industry.

Ulrich Reichert heads the regulatory management - pharma and food materials organization of the life science business of Merck KGaA, Darmstadt, Germany. He is responsible for registration of APIs and excipients with health authorities (master files), and he acts as the principal contact for site registration with the GMP-supervisory authority. Ulrich is a pharmacist by training, holds a Ph.D. and an M.S. in drug regulatory affairs,  and has more than 20 years of experience in quality and regulatory requirements for raw and starting materials in the pharmaceutical industry. 

Jacqueline Ruff is a strategic marketing manager leading marketing initiatives for the growing small molecule CTDMO landscape at Merck. Prior to joining the marketing franchise, she gained experience in small molecule CDMO operations through her roles in project management and quality management. Jackie received bachelor's degrees in both genetics and life science communication at the University of Wisconsin, and her Master's in biotechnology enterprise and entrepreneurship from Johns Hopkins University.