Biopharmaceutical Process Optimization with Simulation and Scheduling Tools

Area of Science:

• Biopharmaceutical Engineering
• Process Systems Engineering
• Computational Modeling

Background:

• Biopharmaceutical process design and assessment vary in detail depending on the product development stage.
• Early-stage development uses preliminary "back-of-the-envelope" assessments.
• Late-stage development requires detailed design and evaluation before facility construction.

Purpose of the Study:

• To describe the application of process simulators, discrete event simulators, and finite capacity scheduling tools in bioprocess development, design, and manufacturing.
• To illustrate the utility of these computational tools across different phases of biopharmaceutical production.

Main Methods:

• Utilizing process simulation for preliminary and detailed design of integrated biopharmaceutical processes.
• Detailed modeling of a single batch bioprocess for therapeutic monoclonal antibody (MAb) manufacturing.
• Developing production planning and scheduling models for multiproduct biopharmaceutical plants.

Main Results:

• Demonstration of how simulation tools facilitate bioprocess development and optimization.
• Application of detailed modeling for specific MAb production processes.
• Implementation of scheduling models for efficient multiproduct plant operations.

Conclusions:

• Process simulation, discrete event simulation, and finite capacity scheduling are valuable tools for biopharmaceutical process development, design, and manufacturing.
• These tools enhance the efficiency and effectiveness of both early-stage assessments and detailed design phases.
• The described methodologies support optimized production planning and scheduling in complex biopharmaceutical manufacturing environments.