Abstract
Facilities must maintain compliance with regulatory standards while maintaining flexibility to manufacture a variety of therapeutic cell types for clinical trials. Careful planning is required when designing a new or modifying an existing facility to maintain compliance with good manufacturing practice/good tissue practice (GMP/GTP) regulations. Likewise, considerable forethought is essential to meet current and anticipate future manufacturing requirements. If these goals are not clearly defined, any new construction or modifications may fail to meet demands. The choice to design a new facility or modify an existing one is often driven by the institutional constraints. There are unique issues associated with both approaches. This chapter focuses on the 36,000 ft2 purpose-built stand-alone facility model in place at the University of Minnesota. This facility currently manufactures a wide range of cellular products that support 80 clinical studies.
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McKenna, D. (2009). University of Minnesota - Molecular and Cellular Therapeutics (MCT). In: Gee, A. (eds) Cell Therapy. Springer, Boston, MA. https://doi.org/10.1007/b102110_4
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DOI: https://doi.org/10.1007/b102110_4
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