Abstract: Systems and methods for manufacturing and distributing somatic cell therapy and gene therapy products are provided. The systems and methods include establishing a central processing facility and a plurality of satellite facilities administered under a single government license for conducting somatic cell or gene therapy, collecting source material at one of the satellite facilities from a first subject, transporting the source material from the first subject and delivering the source material to the central processing facility, processing the source material from the first subject at the central processing facility to produce a therapy product for administration to the same first subject, transporting the therapy product back to the satellite facility and administering the therapy product to the same first subject. All steps are performed under the control of the manufacturer.

Abstract: The present invention includes a syringe device that includes an elongated tubular barrel having a first end and a second end, a plunger telescopically received within at least a portion of the barrel, such that a portion of the plunger extends from the first end of the barrel, and a protective sheath positioned adjacent to an external surface of the portion of the plunger, such that the protective sheath encloses the portion of the plunger extending outwardly from the first end of the barrel. The present invention further includes methods of transporting a biological material within the syringe device, and transferring the biological material between a source container and the syringe device.

Abstract: The present invention includes a bioreactor support system that provides an improved way to culture large quantities of mammalian cells. Mammalian cells are extremely sensitive to their environment, undergoing a programmed cell death in response to nutrient deprivation, growth factor withdrawal, oxygen starvation and excess shear levels. The present invention includes a bioreactor support system which permits the culture of cells at high density and prevents cell death by providing enhanced oxygen delivery to the cells without excessive shear; maintaining cell secreted or exogenously added low molecular weight products (e.g., growth, differentiation and maintenance factors) in the culture space during perfusion culture; and provides the ability to feed the cultures without dilution of the conditioned media. The improved bioreactor support system features two flow paths emanating from a central integrating chamber.

Abstract: A cell growing device for in vitro cell population growth includes at least one hollow fiber cartridge having a plurality of capillaries at least one of which is selectively permeable. The flow of media out of a lumen of the cartridge is substantially blocked off thereby forcing media flowing into the lumen via an inflow opening to permeate across the capillaries of the cartridge and into the extracapillary space thereof.