Autologous cell therapies are derived from a patient’s own stem cells, typically collected from bone marrow. Those cells are then cultured, expanded, and reinfused back into the patient. Unlike allogeneic cell therapies, this process is repeated for each dose and for one patient. The one-to-one process carries several challenges to commercialization, including high development costs, the need to control the risks of manual processing, and compliance with strict timelines.
This BioProcess International eBook presents two perspectives on addressing these challenges. The first article is an interview with George Goldberger from Cell One Partners, a company experienced in consulting biomanufacturers in the development and manufacture of cell and gene therapies. He discusses process challenges, costs, logistics, technologies, and need for innovation for autologous cell therapies. In the second article, Lynn O’Donnell, clinical associate professor of hematology and director of the Cell Therapy Laboratory at The Ohio State University’s James Cancer Hospital and Solove Research Institute, provides her perspective on the clinical side of autologous therapies. She discusses the importance of coordinating therapy development and administration, controlling ancillary material costs, and easing patient burdens.