| 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. |