PROJECT LEADS: Rutgers University
PARTNERS: University of Delaware, Johnson & Johnson
PROBLEM STATEMENT: There is significant market opportunity for the development of SM based platforms to produce pharmaceutical dosage forms such as tablets/capsules. Regulatory authorities such as the U.S FDA have mandated that manufacturing be based more on science- based understanding and data-based analytics compared to the traditional manufacturing practices based on heuristics.
PROJECT GOAL: Develop an integrated SM platform to improve the energy productivity and reduce energy intensity of a pharmaceutical tablet manufacturing process via wet granulation (WG), whilst maintaining other performance metrics such as product quality.
- Real-time measurement and analysis of material attributes
- Develop hybrid models to perform virtual experiments and to optimize energy consumption
- SM-enabled model and data integration for efficient manufacturing
- Demonstrate reduction in energy consumption and re-usability of prototype components
KEY TASKS AND MILESTONES:
- Establish baseline BM process via WG (Case 1). Quantify key performance and energy metrics.
- Establish WG CM process (Case 2). Quantify key performance and energy metrics. Establish integrated SM platform and CM process architecture.
- Performance improvement studies via advanced model development and sensing. Demonstrate reduction in energy usage of 20% moving from Cases 1 to 2.
- Establish optimized BM process via WG (Case 3). Quantify key performance and energy metrics.
- Performance improvement studies via advanced model development and sensing. Demonstrate reduction in energy usage of 30% moving from Cases 1 to 3. Establish optimized CM process via WG (Case 4). Quantify key performance and energy metrics.
- Performance improvement studies via advanced model development and sensing. Demonstrate reduction in energy usage of 50% moving from Cases 1 to 4.
- Process intensification of production which could lead to ~2.5 times reduction in fixed investment
- Much shorter times for a production of therapeutics, in terms of time-to-market
- Cross-cutting innovations that could directly be adapted to other manufacturing industries like biologics, food, specialty chemicals
- Will lead to overall energy and cost savings
- An integrated modeling, sensing, control and data management program leading to improvements in energy productivity and efficiency
- Reduction in costs compared by implementing SM techniques into current traditional manufacturing
- Training students and industrial practitioners on SM techniques and tools
- Improvement of the pharmaceutical supply chain which are currently complex and inefficient
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