Upscaling of Clinical Grade Stem Cell Production: Upstream Processing (USP) and Downstream Processing (DSP) Operations of Cell Expansion, Harvesting, Detachment, Separation, Washing and Concentration Steps, and the Regulatory Requirements

AbstractThis chapter has discussed very important issues in stem cell production for instance, the background of stem cell production, and upscaling of clinical grade stem cell production. The chapter has further highlighted on critical areas of clinical grade stem cell production such as the upstream processing (USP) and downstream processing (DSP) operations of cell expansion, harvesting, detachment, separation, washing and concentration steps, and the regulatory requirements. Then the chapter has provided a recap that has summarized the expanded chapter sections. Finally, this chapter provides a call to action on upscaling of clinical grade stem cell production.Key wordsUpscaling of clinical grade stem cell productionUpstream processingDownstream processing of cell expansionHarvestingDetachmentSeparationRegulatory requirements