Critical Quality Attribute Monitoring and Control in Drug Substance Manufacturing
In past AIChE programming, linkage between drug substance CQAs monitoring and control and clinical performance relevance had not been discussed adequately, despite the fact that 1) patients are ultimate consumers of all of the pharmaceuticals; and 2) drug substance represents one of the main sources of materials’ variability in drug product manufacturing. On the other hand, complicated API manufacturing poses some unique challenges for the drug substance community including regulatory agencies to address. 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.
In this years annual meeting there are two sessions that cover drug substance critical quality attribute identification, characterization, and monitoring systems for both drug substance quality and manufacturing process control:
Authors have been encouraged to highlight clinically relevant specifications for drug substance and innovative control strategies for drug substance manufacturing, providing a collaborative platform to discuss the state-of-the-art drug substance manufacturing trends and some of the technical issues and regulatory challenges among the industry, academia, and regulatory authority.
These two parallel sessions echoes well the enhanced efforts on drug substance development, manufacturing, and regulatory oversight.