Industry 4.0 Implementation in Continuous Pharmaceutical Manufacturing

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Project Summary/Abstract. In the last decade, our Center for Structured Organic Particulate Systems (C-SOPS) team has led the development of the experimental and computational infrastructure needed to enable Quality by Design (QbD) for continuous pharmaceutical manufacturing, working very closely both with the Food and Drug Administration (FDA) and with industry. Moving forward, the future of manufacturing is the industry 4.0 paradigm, which builds upon the current manufacturing trend (industry 3.0 – digital age of automation and information) to move towards more autonomous and de-centralized decisions across the entire manufacturing supply chain. The benefits in moving in this direction are significant and industries have recognized their impact in improving reliability, security, quality and safety. This proposal, which is a conceptual component of a broad initiative led by Rutgers to establish a center of excellence in Continuous Manufacturing, leverages the existing strengths and previous work and successes at Rutgers and Purdue, to develop the next generation pharmaceutical continuous manufacturing (CM) processes in accordance with the Industry 4.0 future standard. The specific aims are: Specific Aim 1: Design and implementation of integrated data management and informatics infrastructure for next generation continuous pharmaceutical processing. Specific Aim 2: Development of process knowledge extraction strategies which utilize the informatics systems established under Aim 1 for intelligent process monitoring, fault diagnosis, material tracking and real time risk assessment. Specific Aim 3: Development and assessment of continuous process improvement strategies using the informatics infrastructure of Aim 1 and knowledge extraction strategies of Aim 2.! The result of this work will be a unique toolset necessary to (i) implement Industry 4.0 in the pharmaceutical industry, and to (ii) enable FDA to regulate such applications effectively. The integrated infrastructure for process and product informatics (as demonstrated in Rutgers and Purdue CM pilot-plants) is a critical part of the full implementation of continuous manufacturing methods for pharmaceuticals. We envision that the knowledge, products, and training emanating from this endeavor, will provide both a practical proof of concept and an implementation blueprint to pursue other, more complex applications including continuous API manufacturing, and continuous manufacturing of biomolecules. The technology transferred in this work will enable enhanced performance of the CM line thus accelerating and broadening its commercialization. Once available, the toolset developed in the proposed work should also be used by regulatory agencies for a wide range of applications, including batch manufacturing, analysis of marginal and suspect products and processes (whether substandard, contaminated, adulterated, or counterfeit), and also applications beyond drugs.