Advancing process control toward intelligent continuous biopharmaceutical manufacturing: Challenges, strategies, and future directions.

Continuous biomanufacturing is increasingly emphasized for productivity, scalability, and process consistency, and robust operational control is needed to maintain consistent product quality under continuous processing.

• Why it matters: Regulatory initiatives such as FDA Quality by Design (QbD) and ICH Q13 highlight a gap in ensuring stable product quality during continuous operations, motivating stronger control approaches.
• What they did: The review systematically analyzes control strategies across unit operations from upstream cell culture to downstream purification, covering feedback, model predictive control (MPC), reinforcement learning (RL), and integration of PAT, model-based control, and digital twin (DT) sensing-modeling-control architectures.
• The result: It outlines how predictive, adaptive, and risk-aware control systems—supported by PAT and digital twins—can enable sustained state of control in interconnected, long-duration continuous biopharmaceutical manufacturing.

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