Designing Cell Therapy Facilities: Leveraging Operational Simulations

Cell therapies are emerging as an important class of next-generation medicines. As many novel treatments move through development to commercialization, manufacturers are challenged to construct optimal facilities for the production of cell therapies. Modeling and simulation at the earliest design stages have many benefits.

The number of cell therapy treatments in development has exploded in recent years. While only a few have received regulatory approval to date, many are moving rapidly from late clinical stage to commercialization. From 2017–2023, the cell therapy market — including stem cell and non-stem cell (some modified via gene editing) autologous (personalized) and allogeneic (off-the-shelf) drugs to treat musculoskeletal, cardiovascular, gastrointestinal, neurological, oncology, dermatology, ocular and other diseases and conditions — is expected to expand at a compound annual growth rate of over 10%.¹

Capacity for the production of cell therapies is currently generally limited to laboratory scale, with most processes involving highly manual operations. As the market expands and volume demands increase, current practices must be modified for scale-out (autologous) or scale-up (allogeneic). New facilities will also be needed to implement larger-volume manufacturing.

Computer modeling and simulations from an operational perspective can support the development of an optimal facility design that will enable cell therapy manufacturers to meet the needs of patient populations.

Designing new facilities for cell therapy manufacturing is a challenging task. Commercialization remains in the nascent stage, with only a few facilities constructed to date. Numerous uncertainties remain, from the potential demand for any given new therapy, equipment technology and equipment reliability, and learning curves for the analysts and operators, to the possible lead times for key raw materials, and many more. All of these factors impact facility design, including plant footprint, the types and numbers of pieces of equipment, the required staff and the flow of people and materials. One approach to managing these uncertainties at the facility design stage is to develop operational models and perform computer simulations.

To learn more about the use of operational models and computer simulations in the design of cell therapy facilities, click here to read the full article:  https://www.pharmasalmanac.com/articles/leveraging-operational-simulations-to-design-cell-therapy-facilities

About the Author: Niranjan Kulkarni, Ph.D. is the Director of Operations Improvement at CRB. He holds a doctorate and master’s degree in industrial and systems engineering from Binghamton University. Niranjan has over 15 years of experience in business process and data modeling, operations and process simulations, process improvements, layout optimizations and supply chain management. He has worked with the pharmaceutical, biotech, food, chemical, semiconductor, electronics assembly and packaging, manufacturing and financial industries.