Project Summary/Abstract.In the last decade, our Center for Structured Organic Particulate Systems (C-SOPS) team has led thedevelopment 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 buildsupon the current manufacturing trend (industry 3.0 – digital age of automation and information) to movetowards more autonomous and de-centralized decisions across the entire manufacturing supply chain. Thebenefits in moving in this direction are significant and industries have recognized their impact in improvingreliability, security, quality and safety.This proposal, which is a conceptual component of a broad initiative led by Rutgers to establish acenter of excellence in Continuous Manufacturing, leverages the existing strengths and previous work andsuccesses 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 fornext generation continuous pharmaceutical processing.Specific Aim 2: Development of process knowledge extraction strategies which utilize the informatics systemsestablished under Aim 1 for intelligent process monitoring, fault diagnosis, material tracking and real time riskassessment.Specific Aim 3: Development and assessment of continuous process improvement strategies using theinformatics 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 pharmaceuticalindustry, and to (ii) enable FDA to regulate such applications effectively. The integrated infrastructure forprocess and product informatics (as demonstrated in Rutgers and Purdue CM pilot-plants) is a critical part ofthe full implementation of continuous manufacturing methods for pharmaceuticals. We envision that theknowledge, products, and training emanating from this endeavor, will provide both a practical proof of conceptand an implementation blueprint to pursue other, more complex applications including continuous APImanufacturing, and continuous manufacturing of biomolecules. The technology transferred in this work willenable enhanced performance of the CM line thus accelerating and broadening its commercialization. Onceavailable, the toolset developed in the proposed work should also be used by regulatory agencies for a widerange of applications, including batch manufacturing, analysis of marginal and suspect products and processes(whether substandard, contaminated, adulterated, or counterfeit), and also applications beyond drugs.
|Effective start/end date||9/1/18 → 8/31/21|
- Food and Drug Administration (FDA)