ROLE OF PLATFORM TECHNOLOGIES AND AI/ML IN ADVANCING PHARMACEUTICAL MANUFACTURING

Published

April 24, 2025

Author(s)

Vishnu Kumar, Vijay Srinivasan

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 timeline when compared to the traditional manufacturing processes. While platform technology is gaining widespread adoption, the lack of a streamlined 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 accelerate the approval of well-established platform technology used in pharma products. 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.

Proceedings Title

Proceedings of the ASME 2025 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference

Conference Dates

August 17-20, 2025

Conference Location

Anaheim, CA, US

Conference Title

ASME 2025 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference

Pub Type

Conferences

Keywords

Pharmaceutical Manufacturing, Product Platforms, Artificial Intelligence (AI), Machine Learning (ML)

Citation

Kumar, V. and Srinivasan, V. (2025), ROLE OF PLATFORM TECHNOLOGIES AND AI/ML IN ADVANCING PHARMACEUTICAL MANUFACTURING, Proceedings of the ASME 2025 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference, Anaheim, CA, US (Accessed May 19, 2025)