Role of Platform Technologies and AI/ML in Advancing Pharmaceutical Manufacturing

Abstract The pharmaceutical (pharma) manufacturing sector is rapidly evolving to meet the global needs for faster, safer, and more efficient therapeutics. A key focus of this change has been the platform-based pharma manufacturing approach, which offers customization, scalability, and shorter development and production timelines when compared to traditional manufacturing processes. While platform technology is gaining widespread adoption, the lack of a streamlined regulatory approval process for platform-based products remains a significant challenge. In response, the US Food and Drug Administration (FDA) has recently introduced the “Platform Technology Designation Program for Drug Development” which aims to expedite the review of drug applications that incorporate well-understood and reproducible platform technologies into both their design and production workflows. As pharma manufacturers look to the future, they are increasingly exploring the integration of platform technology with Artificial Intelligence (AI) and Machine Learning (ML). In the wake of these developments, this paper examines the role of platform technology and platform designation in advancing pharma manufacturing, alongside the integration of AI/ML. By addressing these key topics, their benefits, and critical considerations, this paper aims to provide insights into the potential of platform technologies and AI/ML, thereby offering a roadmap for the future of pharma manufacturing.