Approaching Process Validation During Tech Transfer To Commercial Manufacturing

Matthew Schiesher is Head of Research and Development at Cambrex Charles City, IA, where he has spent 20 years. A synthetic chemist by training, he holds a B.S. in Chemistry from Iowa State University and a Ph.D. in Chemistry from the University of Michigan.

He leads the process and analytical R&D teams that support manufacturing at the site, drawing on experience in process development, cGMP manufacturing, intricate problem solving, and the management of scientific personnel. His technical background spans organometallics and heterocyclic chemistry.

Asked how he approaches process validation during tech transfer to commercial manufacturing, Schiesher points to the pressure of time-critical programs, where patients are waiting on the medicine. Those situations are among the harder aspects of transfer and validation — but he notes that the wider Cambrex network can be brought to bear, with multiple sites working in parallel to compress the timeline for launching a new program.