Data and AI Enablement in Pharmaceutical CMC Manufacturing: Challenges, Use Cases, and Talent Strategy

Abstract

This paper examines key challenges in pharmaceutical chemistry, manufacturing, and controls (CMC) operations and manufacturing, and identifies areas where data and artificial intelligence (AI) can deliver practical value. It presents actionable solutions illustrated by specific use cases. Furthermore, it proposes a classification of talent profiles required for the sustainable adoption of data- and AI-driven approaches and summarizes the challenges and strategies for acquiring and developing such talent. This paper is intended for a broad audience, including professionals in manufacturing, quality, engineering, and digital/IT functions.