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.

TECHNICAL APPROACH:

  • 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.

POTENTIAL IMPACT:

  • 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

BENEFITS:

  • 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

practices

  • Training students and industrial practitioners on SM techniques and tools
  • Improvement of the pharmaceutical supply chain which are currently complex and inefficient
Member % Cost Share CESMII % Cost Share Duration
50.07% 49.93% 18 Months

 

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