“ 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.