Freeze drying can be a complex operation requiring the development of a complex process design, and largely because of this complexity and the lack of adequate process analytical technology, most commercial freeze drying processes are suboptimal, thereby wasting time and/or placing product quality at risk.
The project team will develop and test new automated tools for the development and scale-up of pharmaceutical lyophilization processes. These tools will provide a standardized approach for process development and scale-up.
Modeling tools and sensors to enable lyophilization process development and scale-up.
This proposed R&D effort will produce standardized, automated approaches to lyophilization process development and process scale-up. The proposed process development approach could save pharmaceutical companies up to 22 days when compared to the use of a Design of Experiments (Box-Behnken) approach. We estimate that this is worth ~$66M for manufacturing 26 of some pharmaceutical products ($3M/day value of drug product sales). The proposed process scale-up approach, which will result in improved commercial scale design space, could save product batches following process deviations. The value of a single batch of pharmaceutical product can vary from $500K to >$5M. In addition, saving product batches may also prevent shortages of life saving drugs. This proposed program will develop a lyophilization user facility at UML, advances workforce training through UML, UConn, and Purdue. UConn and Purdue are LyoHub members, an industry-led lyophilization science consortium.
Aseptic pilot scale lyophilizer R&D facility at UMass Lowell User friendly lyophilization primary drying process development and scale up model that accounts for process heterogeneity Simplified CFD based computational model to predict the mass flow rate lyophilizer equipment capability curve.
Kazarin, P., Kessler, W., Gong, E., Yoon, S., Liu, H., Marx, R., Bogner, R., & Alexeenko, A. (2021). A Compact Model for Lyophilizer Equipment Capability Estimation. AAPS PharmSciTech, 23(1), 14. https://doi.org/10.1208/s12249-021-02167-8
Kazarin, P., Alexeenko, A., Kessler, B., Gong, E., Hinds, M., Bogner, R. H., Manchanda, A., Yoon, S., Liu, H., Sharma, P., Kumar, L., Lim, F., Bhambhani, A., & Stanbro, J., CFD Modeling and Analysis of Freeze Drying Process in the Context of Pharmaceutical Lyophilization Scale-up, East Coast Annual Meeting of the International Society for Lyophilization and Freeze-Drying, Rockville, MD, September 17, 2019.
Kazarin, P., Alexeenko, A., Kessler, B., Gong, E., Hinds, M., Bogner, R. H., Manchanda, A., Yoon, S., Liu, H., Sharma, P., Kumar, L., Lim, F., Bhambhani, A., & Stanbro, J., CFD Modeling and Analysis of Freeze Drying Process in the Context of Pharmaceutical Lyophilization Scale-up, UMass Lowell Lyophilization Facility Ribbon Cutting & Grand Opening Ceremony, Lowell, MA, October 28, 2019.
Kessler, B., Gong, E., Hinds, M., Bogner, R. H., Manchanda, A., Yoon, S., Liu, H., Alexeenko, A., Kazarin, P., Sharma, P., Kumar, L., Lim, F., Bhambhani, A., & Stanbro, J., Software and Hardware Tools for Pharmaceutical Lyophilization Scale-up, East Coast Annual Meeting of the International Society for Lyophilization and Freeze-Drying, Rockville, MD, September 17, 2019.
Kessler, B., Gong, E., Hinds, M., Bogner, R. H., Manchanda, A., Yoon, S., Liu, H., Alexeenko, A., Kazarin, P., Sharma, P., Kumar, L., Lim, F., Bhambhani, A., & Stanbro, J., Software and Hardware Tools for Pharmaceutical Lyophilization Scale-up, UMass Lowell Lyophilization Facility Ribbon Cutting & Grand Opening Ceremony, Lowell, MA, October 28, 2019.
Liu, H. & Yoon, S., Development of a pilot scale freeze drying facility in an ISO 5 environment, 2019 Process Systems Enterprise Advanced Process Modelling Forum, Greenburgh, NY, September 10, 2019.
Liu, H., Yoon, S., Kessler, B., Gong, E., Hinds, M., Bogner, R. H., Manchanda, A., Alexeenko, A., Kazarin, P., Sharma, P., Kumar, L., Lim, F., Bhambhani, A., & Stanbro, J., Development of a pilot scale freeze drying facility in an ISO 5 environment, East Coast Annual Meeting of the International Society for Lyophilization and Freeze-Drying, Rockville, MD, September 17, 2019.
Liu, H., Yoon, S., Kessler, B., Gong, E., Hinds, M., Bogner, R. H., Manchanda, A., Alexeenko, A., Kazarin, P., Sharma, P., Kumar, L., Lim, F., Bhambhani, A., & Stanbro, J., Development of a pilot scale freeze drying facility in an ISO 5 environment, UMass Lowell Lyophilization Facility Ribbon Cutting & Grand Opening Ceremony, Lowell, MA, October 28, 2019.
Kessler, B., Bogner, R. H., Yoon, S., Alexeenko, A., Sharma, P., Kumar, L., Bhambhani, A., Stanbro, J., & Lim, F., Software and Hardware Tools for Pharmaceutical Lyophilization Scale-up, NIIMBL National Meeting, Washington, DC, June 28, 2019.
Software and Hardware Tools for Pharmaceutical Lyophilization Scale-up (SP1.0-003), NIIMBL Member Forum, Virtual, February 26, 2021.
Software and Hardware Tools for Pharmaceutical Lyophilization Scale-up (SP1.0-003), NIIMBL Member Forum, Virtual, October 31, 2019.
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Physical Sciences Inc
Genentech, Inc.
Massachusetts Life Sciences Center
Merck Sharp & Dohme LLC
National Institute for Pharmaceutical Technology and Education, Inc (NIPTE)
Purdue University
University of Massachusetts Lowell
