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ISPE official magazine: Biopharma/ Cell+Gene Therapy

Cell and Gene therapies gained attention in recent years with their potential in alleviating the underlying cause of genetic diseases and acquired diseases. In the emerging cell and gene therapy space, strategic facility planning can help investors and manufacturers to ensure that their facilities will be sufficient to adopt new technologies and processes. A recent article from Pharmaceutical Engineering Magazine November-December 2020 Volume 40. Number 6 highlighted this topic.


“ Designing new facilities for cell and gene therapy manufacturing is a challenging task given the many uncertainties in this industry sector, including varying potential demand for any given new therapy, evolving platforms and technology, questions about equipment reliability, learning curves for analysts and operators, possible sourcing issues, and variable lead times for key raw materials. All these factors influence facility sizing, equipment quantities, required head count, and the flow of people and materials.” By Niranjan S. Kulkarni, PhD from ISPE article Nov/Dec 2020.


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