Design Space Identification and Visualization for Continuous Pharmaceutical Manufacturing

Area of Science:

• Chemical Engineering
• Process Chemistry
• Pharmaceutical Manufacturing

Background:

• Continuous flow chemistry has advanced Active Pharmaceutical Ingredient (API) synthesis over two decades.
• Continuous Pharmaceutical Manufacturing (CPM) offers reduced waste, energy, costs, and access to hazardous process windows.
• Design space investigation is crucial for understanding process performance and product quality before extensive experimentation.

Purpose of the Study:

• To review literature on design space investigation and visualization for continuous API production.
• To highlight attainable regions for recoveries, material efficiencies, and cost components in upstream processing.
• To provide insights into optimizing Continuous Pharmaceutical Manufacturing (CPM) operations.

Main Methods:

• Literature review of design space investigation and visualization techniques.
• Modeling and simulation of upstream processes (reaction and separation).
• Nonlinear optimization to identify optimal operating conditions.

Main Results:

• Demonstrations of design space exploration for continuous API manufacturing.
• Identification of achievable ranges for key performance indicators like recovery and material efficiency.
• Analysis of cost components and flowsheet complexity in upstream CPM.

Conclusions:

• Design space investigation provides valuable insights for optimizing continuous API production.
• Modeling and optimization are effective tools for defining optimal CPM operational parameters.
• Understanding attainable regions is key to efficient and cost-effective Continuous Pharmaceutical Manufacturing (CPM).