Streamlining data management in drug product commercialization and manufacturing

Abstract

Effective execution and alignment of data management across development and manufacturing teams is essential for Amgen's Drug Product Technology group to realize its main goals of shortening the development timeline and ensuring robust commercial manufacturing. The right data management strategy can help address these goals by accelerating development work and regulatory filing as well as improving commercial manufacturing efficiency. In the face of challenges associated with rapid growth and an expanding product pipeline, Amgen's commitment to standardizing development work and digitizing both clinical and commercial manufacturing has introduced many opportunities for new data management initiatives, improvements, and a revamped overall data management strategy. We identify a framework for the development of a data management strategy for the Drug Product Technology group to enable greater efficiency and alignment across development and manufacturing teams. The primary steps in data management and objectives at each step were determined. While a full data management strategy has been recommended to the Drug Product Technology group as a set of current and future projects, this thesis focuses on three specific case study projects within the overall strategy: (1) data generation and collection in drug product manufacturing, (2) real-time multivariate statistical process monitoring of lyophilization in clinical manufacturing, and (3) integration of development study data through electronic lab notebook software. Based on insights from these case studies, we make specific recommendations for further improvements in data management.