(705b) Scientific Considerations and Regulatory Challenges for Low Dose Drug Manufacturing Process Monitoring and Control
- Conference: AIChE Annual Meeting
- Year: 2017
- Proceeding: 2017 AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
Thursday, November 2, 2017 - 12:52pm-1:14pm
In this presentation, we will discuss scientific case studies excerpted from research studies and drug applications, challenges and opportunities, along with considerations for low dose drug manufacturing process monitoring and control. Specific attention will be paid to the easily overlooked or under-reported areas such as: 1) risk-based PAT monitoring interface location considerations for both batch processing and continuous manufacturing; 2) evaluation of engineering process scale-up criteria as applied to powder blending process; 3) sampling and analytical methods. Our discussion will illustrate a holistic approach supported by solid scientific understanding for low dose drug manufacture.