MANUFACTURING PROCESSES AND STRATEGIES FOR CELL AND GENE THERAPY PRODUCTS

摘要

The development of novel, affordable and efficacious therapeutics will be necessary to ensure the continued progression in the standard of global healthcare. With the potential to address previously unmet patient needs as well as tackling the social and economic effects of chronic and age-related conditions, cell and gene-based therapies (CGTs) will lead the new generation of healthcare products set to improve global health and wealth. However, it is estimated that lot size requirements will exceed billions or even trillions of cells, a demand which cannot be supplied by current production methods. The difficulties associated with the translation of efficacious CGTs is not limited to developing our biological understanding of the cell, but rather encompasses engineering, biomanufacturing, regulatory, commercial and clinical challenges which must be addressed in parallel.