Cell therapy system
First Claim
1. A therapy method, comprising:
- a) establishing a central processing facility and a plurality of satellite facilities for conducting somatic cell or gene therapy;
b) collecting source biological material at one of the satellite facilities from a first subject;
c) transporting the source material from the first subject and delivering the source material to the central processing facility;
d) processing the source material from the first subject at the central processing facility to produce a therapy product; and
e) transporting the therapy product back to the satellite facility for administration to a subject, wherein all steps are performed, such that the manufacturer has vein-to-vein control over the processes, facilities and products, and source material is tracked from collection through processing to infusion of the product derived from the source material.
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Accused Products
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.
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Citations
63 Claims
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1. A therapy method, comprising:
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a) establishing a central processing facility and a plurality of satellite facilities for conducting somatic cell or gene therapy;
b) collecting source biological material at one of the satellite facilities from a first subject;
c) transporting the source material from the first subject and delivering the source material to the central processing facility;
d) processing the source material from the first subject at the central processing facility to produce a therapy product; and
e) transporting the therapy product back to the satellite facility for administration to a subject, wherein all steps are performed, such that the manufacturer has vein-to-vein control over the processes, facilities and products, and source material is tracked from collection through processing to infusion of the product derived from the source material. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 59, 60)
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47. A cell therapy system that for production of a therapy product, comprising:
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a plurality of satellite facilities, wherein each satellite facility collects a source material from a subject, administers the therapy product to the subject, or any combination of any of these; and
a central processing facility that is connected to each satellite facility, wherein the central processing facility processes the source material to form the therapy product, wherein;
a single manufacturer controls all satellite and central processing facilities; and
the cell therapy system is effective to collect source material from a subject, transform the source material into the autologous therapy product, and administer the therapy product to a subject. - View Dependent Claims (48, 49, 50, 51, 52, 53, 61, 62, 63)
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54. A method of producing an autologous somatic cell therapy product, comprising:
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processing a subject at a satellite facility to identify and track the subject;
obtaining source material from the subject;
transforming a source material into the autologous somatic cell therapy product at a central processing facility connected to the satellite facility via a computer network, wherein all steps are performed, such that the manufacturer has vein-to-vein control over the processes, facilities and products. - View Dependent Claims (55, 56, 57, 58)
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Specification