PFI:AIR-RA: Commercializing Pharmaceutical Process Modeling for Continuous Manufacturing

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This PFI: AIR Research Alliance project focuses on the translation and transfer of pharmaceutical process modeling for continuous manufacturing, derived from the Engineering Research Center for Structured Organic Particulate Systems (ERC-SOPS). The high cost of pharmaceuticals has a direct effect on healthcare costs and is a financial burden on uninsured or underinsured populations in the US. In the developing world, people suffer or die from curable or treatable diseases and illnesses due to a lack of affordable pharmaceuticals. Reducing manufacturing costs through innovations and technology transfer represents an opportunity to significantly bring down the cost of pharmaceuticals. At the present most pharmaceuticals are produced using batch manufacturing technology. In a batch process all of the material is processed at the same time leading to typical equipment that is meters in size that would process hundreds of kilograms of material. Not only is it problematic to process so much material at once, many pharmaceutical manufacturing processes have changed little in decades, and are expensive and difficult to scale. Replacing batch manufacturing of pharmaceuticals with continuous manufacturing is a major technology advance that can change the landscape of pharmaceutical manufacturing in the next decades. In a continuous process, material flows continuously through the system so typical equipment would be tens of centimeters in size and would process a few hundred grams of material at a time. Continuous manufacturing of pharmaceuticals has the potential to be transformative by simplifying development and scale up, and allowing major changes in production. This will result in lower development and production costs for the pharmaceutical industry, and higher quality products and more robust manufacturing processes that will reduce manufacturing costs and benefit society as a whole. An industry/academic innovation ecosystem will be established for the development and commercialization of pharmaceutical process modeling for continuous manufacturing. The innovation ecosystem that will be created includes Janssen Supply Group, Patheon and Control Associates/QbD Process Technologies. A framework for connecting the process models will be established, and these will be linked to available control models in an integrated system. The potential economic impact is expected to be development of process models and commercial modeling software and creation of new jobs in the next 3-5 years. Students and post-doctoral fellows will gain entrepreneurial and technology translation experience through training materials, seminars and meetings with entrepreneurs. An essential part of the development of continuous pharmaceutical processes and the implementation of continuous manufacturing of pharmaceuticals is modeling of these processes. In this project, integrated models will be developed to replace the current mode of trial-and-error design of a continuous manufacturing system. The integrated models will allow for model guided experiments and state-of-the-art process design and will be developed as part of the ecosystem and then commercialized. In this ecosystem, a repository of unit operations will be developed that can be used to model continuous manufacturing of pharmaceuticals. The end product will include a process model library consisting of unit operations, a controller model library that includes different kinds of controllers, and finally the capability of connecting all of these libraries of process templates.