Abstract

Primary and Stem Cell Biomanufactruing Approaches and Successes

William Whitford, Strategic Solutions Leader, GE Healthcare

There are many calls for manufacturing systems involving the culture of stem and primary cells. They range from support of clinical or companion diagnostics; drug discovery using in vitro tissue and organ models; viral infection modeling; tumor phenotypic screening; ADMET and PK/PD support, cell mass expansion for such exciting new goals as 4D bioprinting as well as other clinical therapeutics. Sponsors often have their choice of cell platforms, production formats, culture modes and manufacturing equipment to support this in small-scale for product and process development. However, their commercial success can be dependent upon the discovery or development of scalable GMP manufacturing technologies that can produce very large amounts of cells in a robust, compliant and cost-effective manner. The culture and expansion of primary and stem cells in larger-scale formats can be accomplished in new technologies adapted to meet the above commercial applications. Recent trends include those formats supporting single-use manufacturing and continuous processing.