Critical Quality Attribute Monitoring and Control in Drug Substance Manufacturing I

Developing robust drug substance production processes to ensure patient safety and drug efficacy is dependent on the sound understanding and control of the drug substance quality attributes relevant for clinical performance and drug product manufacture. This understanding is then translated into the design of the drug substance manufacturing process and a relevant monitoring and control system to ensure that quality attributes within the desired ranges are consistently obtained. This session covers drug substance critical quality attribute identification, characterization, and monitoring systems for both drug substance quality and manufacturing process control. Authors are encouraged to highlight clinically relevant specifications for drug substance and innovative control strategies for drug substance manufacturing.