(636e) Protein Management in Biocatalytic Processes: Strategies for Development and Scale-up

Robust protein-product separation remains a key challenge for the successful commercial implementation of biocatalysis in pharmaceutical manufacture and as it can significantly impact the final product's quality, yield, and scale-up efficiency. Existing protein-product separation strategies, including filtration, precipitation, extraction, and immobilization, suffer from challenges such as volumetric inefficiency, poor protein rejection, and high product loss. As a result, protein-product separation operations require significant engineering resources to develop, introduce substantial risk and process variability, and can negatively impact process productivity and yield.

In this talk, we will present case studies from late-stage development campaigns to discuss the challenges and effective strategies we evaluated for protein removal in biocatalytic processes during development and scale-up. The discussion will address the key factors that must be considered when selecting protein removal techniques, including the characteristics of the protein being removed, the desired level of purity, and the potential impact of the removal technique on the biocatalytic process. We will provide practical insights into data-rich strategies used for the development and scale-up of biocatalytic processes, emphasizing the importance of effective protein removal throughout the process and highlighting available techniques we employ to achieve this goal.