Quality by design aproaches to clarification in monoclonal antibody processing

WEBINAR

In this webinar, you will learn about:

• Quality by design
• Process characterization & scale down, risk assessment, establishing design space and control strategy for clarification for monoclonal antibody to achieve high process efficiency and purity

Quality by design (QbD) is a modern, scientific approach promoted by health authorities to improve the quality of therapeutic products which requires deep understanding of both product and process.

This seminar will provide an overview on principles of QbD for a harvest clarification process in monoclonal antibody processing; where the product of interest is extracellular and impurities are removed in the filtrate post-clarification. It will include methods for optimizing the clarification unit operation using QbD principles, ensuring better process efficiency, and product quality.