Software and Hardware Tools for Pharmaceutical Lyophilization Scale-up

This project aims to develop and test hardware and software tools that will harmonize pharmaceutical lyophilization process development and scaleup. These tools (models, procedures and sensors) are targeted for application by R&D scientists.

Industry Need

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.

Approach

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.

Impacts

Modeling tools and sensors to enable lyophilization process development and scale-up.

Outputs/Deliverables

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.

Publications

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.

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

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.

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.

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.