Artificial Intelligence in Good Manufacturing Practices: Governing the Emerging Challenge of Algorithmic Control

Adoption of artificial-intelligence (AI) and machine-learning (ML) tools offers great promise to the future of biomanufacturing. But regulatory guidances must still evolve in order for such novel technologies to reach their full potential without impacting product quality and safety. The foundations for those guidelines already exist; regulatory bodies and biomanufacturers must continue to work together to adapt AI tools while maintaining compliance.

In this BioProcess International eBook “AI and Automation — Governance for Rising Technologies,” Kaisong Zhou, Ph.D., Chairman and CEO and Sun Chau Siu, Ph.D., Executive Director of Regulatory Affairs and Project Management, examine how the governance of AI systems is evolving from models centered on one-time validation toward life-cycle–based paradigms. They share operational applications of such systems in biomanufacturing, including a successful use case of AI tools that predicted a protein A chromatography breakthrough.