Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing...

Area of Science:

• Chemical Engineering
• Process Control
• Pharmaceutical Manufacturing

Background:

• Continuous manufacturing offers advantages over batch processing in pharmaceutical production.
• Effective control systems are essential for ensuring drug product quality and process efficiency.
• Existing challenges in continuous pharmaceutical processing require advancements in control systems engineering.

Purpose of the Study:

• To outline challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing.
• To facilitate the development and deployment of control systems technologies for ensuring drug product quality.
• To address the specific needs of small-molecule and biological drug product manufacturing.

Main Methods:

• Discussion of current status and technical needs in process monitoring, control, systems integration, and risk analysis.
• Exploration of direct measurement, model-based predictions (first-principles and empirical), and design space approaches.
• Analysis of strategies for universities, regulatory bodies, and industry to overcome barriers.

Main Results:

• Continuous manufacturing success relies on meeting critical quality attributes (CQAs), not just steady-state operation.
• Start-up/shutdown procedures and material traceability (using residence time distributions) significantly impact economic viability.
• Control systems must ensure quality amidst disturbances, dynamics, uncertainties, nonlinearities, and constraints.

Conclusions:

• Collaboration between industry, academia, and regulatory bodies is vital for advancing control systems in continuous drug manufacturing.
• Increased federal funding, university-industry partnerships, and regulatory clarity are needed to foster innovation.
• Enhanced training and development of control systems engineering expertise are crucial for successful implementation.