AI, IoT, and the Future of Biopharma Manufacturing

Artificial intelligence (AI) and the Internet of Things (IoT) are about to revolutionize the biopharmaceutical industry. As these technologies are combined and continue to evolve, they can drastically streamline processes from discovery through manufacturing and distribution, making them more efficient and more effective.

AI and IoT are standard in many industries but not, it seems, in biopharma. A recent paper notes that between 2019 and 2023, only about 19% of the biopharma papers reviewed mentioned AI. Only 25% mentioned IoT.

“Even though AI and IoT hold great potential, their application in pharmaceutical manufacturing has been limited,” Reshma Kodumuru, first author, and principal CVS engineer, KBI Biopharma, tells GEN. Reasons include “difficulty in obtaining regulatory approval for decisions driven by AI and of incorporating new technologies into existing workflows, and also by lack of required infrastructure, a shortage of qualified personnel, and a deficiency in understanding how to effectively deploy these technologies.”

Potential benefits, however, are significant. One of the greatest advantages for biopharmaceutical manufacturers, according to Kodumuru and colleagues from Novartis, Grail, and Michigan Technical University, is IoT’s ability to process information “at the edge of the network. It cuts down on latency to the extreme, and therefore increases responsiveness… that is critical in key processes.”

The ability of AI and IoT to power predictive analytics for advanced drug manufacturing is another substantial advantage. Currently used for predictive maintenance and quality control, they predict it soon will be extended to demand forecasting, supply chain management, and personalized medicine.

Several companies, including Novartis, Eli Lilly, Roche, and Pfizer, already deploy these technologies for real-time monitoring to predict equipment failures, adjust process deviations, reduce packaging errors, and increase throughput.

Looking forward, the scientists predict the coupling of quantum computing with AI to solve problems that classical computing can’t solve. Amazon, Google, and Microsoft are each developing quantum computing chips, so quantum computing may be merely years—rather than decades—away.

Implementing AI+IoT

When implementing a combined AI/IoT strategy, Kodumuru says, “Comprehensive data management practices and cybersecurity strategies are among the things that are mostly overlooked by companies. They may not confirm data integrity and security when implementing AI+IoT, which are critical for compliance and operational effectiveness.” They also may neglect to adequately train employees to use the new technologies, “which leads to adoption and scalability challenges,” she continues. “Moreover, the implementation of ethical and regulatory rules in the methods is neglected.”

Therefore, Kodumuru and colleagues advise biopharmaceutical manufacturers to:

  • Assess their technology to pinpoint where AI and IoT can enhance efficiency, quality, and compliance
  • Upskill their workforce
  • Pilot the feasibility and effectiveness of AI+IoT implementations
  • Review and ensure good data management practices
  • Engage regulators around potential AI+IoT compliance concerns
  • Develop a comprehensive cybersecurity strategy

“Pharmaceutical manufacturing is at that very critical juncture where a host of new technologies converges,” they note. It is, in fact, on the cusp of the next technological revolution.