Artificial Intelligence Empowering Process Analytical Technology and Continued Process Verification in Biotechnology

There has been great progress in both Process Analytical Technology (PAT) analytics and process validation within pharmaceutical manufacturing. Advanced analytical techniques and monitoring instrumentation have resulted in increases in the amount and type of data generated. Artificial intelligence (AI) tools are now dramatically improving our capability to both govern and employ these data. One example of AI’s power is its capability to advance the third stage of process validation lifecycle in drug manufacturing: continued process verification (CPV). Governing and standards bodies are working to ensure the safety, efficacy, and quality of products employing AI and AI-driven PAT tools within the lifecycle framework of Good Automated Manufacturing Practice (GAMP 5). Despite this work, and published case studies, sponsors remain in need of generic, platform guidance to direct the practical validation of specific AI-enabled systems in a particular GxP application.