Scale-Up Considerations For Large-Scale Peptide Manufacturing

Scale-up Considerations for Large-Scale Peptide Manufacturing: Factors & Parameters to Address for Implementing Large-Scale Peptide Processes

With Dr. Robert Topping, Distinguished Scientist, CordenPharma Colorado

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.

Key Learning Objectives:

• Learn how large is large-scale peptide manufacturing.
• What are the factors that change on large-scale manufacturing which could impact product quality & process operations?
• What are the areas of risk encountered when scaling up?
• Review safety, health & environmental considerations.