Rapid translation of a cellular therapeutic from research to clinic
Cell & Gene Therapy Insights 2022; 8(3), 445
Cell therapies face regulatory and manufacturing challenges long before they are accessible to patients. Even as therapies prove effective and safe, raw material and manufacturing decisions made during early development can either stall progression or rapidly accelerate it. Utilizing scalable manufacturing processes and translation friendly raw materials during product development of MSCs and extracellular vesicle (EV) therapies will enable cell therapy developers to accelerate leading candidates into clinical trials, ultimately enabling more curative treatments to reach patients.