Product Quality Attribute Monitoring and Control in Drug Substance Manufacturing

Ensuring drug substance production processes remain robust yet ensuring patient safety and drug efficacy is founded on understanding and control of both the process and the product. An understanding of the product requires knowledge of how the product interacts with human physiology leading to an understanding of critical quality attributes that supports efficacy and safety. This understanding is then translated into the process design and characterization of operating space. This session covers the identification and understanding of product quality attribute identification, characterization, and related process/product monitoring and control.