Biopharma Embraces AI in Manufacturing as Regulation Shapes Adoption Pace

The biopharmaceutical industry is deploying artificial intelligence across manufacturing operations, with process development and visual inspection emerging as the most common applications, according to the European industry group IFMPA.

Sergio Cavalheiro Filho, regulatory affairs manager at the Geneva-based organization, said the sector has already been convinced of AI's merits. Deep learning algorithms and computer vision are helping reduce false reject rates, minimize manual re-inspection, prevent delayed product releases, and reduce the loss of compliant product, the group noted.

The pace of adoption now hinges on regulatory frameworks. "A harmonized risk management framework for AI models in the pharmaceutical sector can support manufacturers to adopt AI for increased agility and efficiency and advance the safe and effective use of AI in pharmaceutical manufacturing," Cavalheiro Filho said. He added that clarification in areas like risk management would benefit the industry.

(The assessment comes as pharmaceutical manufacturers face pressure to improve efficiency while maintaining strict quality standards in a heavily regulated environment.)

The pharmaceutical sector's AI deployment follows a broader pattern across manufacturing industries, where computer vision and predictive analytics have been adopted to reduce waste and improve throughput. Unlike consumer-facing AI applications, manufacturing use cases emphasize reliability and auditability—qualities that align with pharmaceutical quality assurance requirements but also demand clear regulatory guidance before widespread implementation.