Future-Ready Process Control: Enabling AI And Digital Transformation In Pharma

By Stefan Hyde, Automation Manager, Asahi Kasei Bioprocess

Technological innovation is the key to addressing growing demand for complex modalities, helping manufacturers pursue faster timelines, more efficient manufacturing workflows, and quality by design approaches. The International Society for Pharmaceutical Engineering (ISPE) has deemed the digital transformation in pharma manufacturing, “Pharma 4.0 ”, which encompasses cloud-based platforms, AI, automation, smart manufacturing solutions, predictive maintenance, digital twins, and more. With these capabilities at hand, manufacturers can improve their connectivity and reduce costs to meet patient needs.

Despite the exciting opportunities of digital innovation, installing new technologies and workflows may trigger concerns around protecting data integrity, maintaining traceability, preventing AI hallucinations, and ensuring compliance with FDA 21 CFR Part 11 and EU Annex 1. Though some manufacturers may hesitate to adopt these technologies, failing to adapt can limit agility in the years to come. Download the full article to explore how these technologies can deliver integration, stability, and compliance without compromising program integrity.