Technology is advancing at an extraordinary rate. Industries are benefiting from automation and AI. As technological developments continue to reform the way industries run, the integration of AI and machine learning technologies in the life sciences industry is redefining the traditional approach to commissioning, qualification, and validation (CQV) in pharmaceutical manufacturing.

The integration of artificial intelligence (AI) and machine learning (ML) into bioprocess development represents a rapid shift in the way discovery, development, optimization, and production of biological products are approached.

Advances in pharmaceutical regulation and pharmaceutical technology don’t always coincide. Each advancement moves on its own schedule, driven by its own unique forces. But sometimes there is a synergy, when advances in technology can help regulators to achieve their objectives and changes in regulation come at just the right time to enable a technology to be impactful. This interplay between innovation and compliance will take center stage at the 2025 ISPE Aseptic Conference, particularly in the "Regulations and Pharma 4.0" track.