chapter  6
29 Pages

Bioprocessing of Human Stem Cells for Therapeutic Use through Single-Use Bioreactors

WithAletta C. Schnitzler, Mark Lalli, Manjula Aysola, Janmeet Anant, Julie Murrell

The field of regenerative medicine has achieved exciting advances in the use of cellular therapies to treat a range of diseases from lymphomas to tissue degeneration. This chapter describes points to consider for the development of cell therapy manufacturing processes that can support production of cells for clinical trials and commercialized products. Planar culture vessels have been widely used in research and can generate moderate numbers of adherent-dependent cells, yet achieving batch sizes into the billions of cells necessitates higher capacity, scalable platforms. By leveraging microcarrier technology, stirred-tank bioreactors address the limitations associated with planar culture and can meet lot size demands in a single production vessel that is monitored and controlled. Although the regulatory environment for advanced-therapy medicinal products is evolving, good manufacturing practices are the guiding principles used to meet standards with the overarching goal of producing therapies that are safe, effective, and consistent. The early adoption of single-use and closed systems enables a smooth progression through the clinical testing, aids in meeting regulatory standards, and ensures that therapeutic advances reach patients in need.