Factors & Parameters to Address for Implementing Large-Scale Peptide Processes
The chemical and operational challenges and risks of peptide synthesis are magnified when considering the transition from lab-scale preparation to large-scale plant manufacturing. Scaling a process can compound the economic and quality risks of not having complete understanding and control of the critical elements that influence the quality, operability and safety of a successful peptide production program.
Many factors have evolved to increase the need for large-scale peptide API manufacturing. The very growth, diversity and evolution of peptide therapeutics that creates the need for large-scale peptide manufacturing also drive the complexity & variability of the synthetic approaches, scale-up strategies and controls that need to be applied. The variability encountered with each new peptide product presents a myriad of challenges during scale-up of not only the synthesis, but can also impact the stability, purity & processability during down-stream processing.
The synthesis, purification and isolation of a peptide product all have interdependent impacts on the quality of the product. In addition to the science of scale-up manufacturing, the support roles and strategies around equipment, campaign management, raw material procurement, waste management and safety also have changing impacts when applied to large-scale.
This webinar will identify aspects of scale-up peptide manufacturing that the CordenPharma Colorado manufacturing site has focused on for large-scale development and implementation of commercial peptide APIs. These aspects, along with their associated benefits & challenges, will be presented as topics that an organization needs to consider, identify and manage in order to prepare & develop successful manufacturing strategies and process controls.
Robert Topping, PhD,
Bob received a B.S. degree in Chemistry from the State University of New York at Fredonia in 1981 and a Ph.D. in Chemistry from Duke University in 1986. After a one year postdoctoral appointment in the Center for Molecular Toxicology at Vanderbilt University, he started his industrial career with Syntex Chemicals in Boulder, Colorado in 1987 as a process development chemist, developing and transferring manufacturing processes to various world-wide Syntex manufacturing sites. Bob continued his work at the Boulder site after the site’s acquisition by Roche, working on the development and implementation of the large-scale manufacturing process for Enfuvertide, as well as other peptide and potent APIs. Bob was Manager of the Synthetic Chemistry Group at Roche Colorado prior to his promotion to Director of Quality Assurance and Customer Service, when the Boulder Roche site was acquired by CordenPharma. Bob is currently a Distinguished Scientist at CordenPharma Colorado, continuing development and implementation of manufacturing processes for peptide and highly potent APIs.