End-to-end cell therapy automation
AssigneesLonza Walkersville, Inc., Lonza Cologne GmbH, Octane Biotech Inc.
InventorsYaling Shi, Erika McAfee, Samatha Bandapalle, Ann Siehoff, Timo Gleissner, Joseph O'Connor, Eytan Abraham, Kelly Purpura, Nuala Trainor, Timothy Smith
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Abstract
The present disclosure provides an automated method of producing genetically modified immune cells, including chimeric antigen receptor T (CAR T) cells, utilizing a fully-enclosed cell engineering system.
Claims36
A method for automated production of a genetically modified T cell culture, the method comprising:
- (a) activating a T cell culture with an activation reagent selected from an antibody and a dendritic cell to produce an activated T cell culture;
- (b) transducing within a cell culture chamber the activated T cell culture with a viral vector encoding an ectodomain, a transmembrane domain, and an endodomain, to introduce the viral vector into the activated T cell culture and produce a transduced T cell culture;
- (c) expanding within the cell culture chamber the transduced T cell culture;
- (d) concentrating the expanded T cell culture of (c);
- and
- (e) harvesting the concentrated T cell culture of (d) to produce a genetically modified T cell culture,
- further comprising washing either or both the expanded T cell culture and the concentrated T cell culture,
- wherein (a) through (e) are performed within a fully enclosed cell engineering system, and the cell culture chamber has a fixed area, and
- wherein expansion of the transduced T cell culture in (c) produces at least 20% more genetically modified T cells than expansion utilizing manual cell culture with a flexible, gas permeable bag.
A method for automated production of a chimeric antigen receptor T (CAR T) cell culture, the method comprising:
- (a) activating a T cell culture with an antibody to produce an activated T cell culture, wherein the antibody and activating conditions promote the phenotype of the genetically modified T cell culture;
- (b) transducing within a cell culture chamber the activated T cell culture with a viral vector encoding a chimeric antigen receptor having an ectodomain, a transmembrane domain, and an endodomain, to produce a transduced CAR T cell culture;
- (c) expanding within the cell culture chamber the transduced CAR T cell culture;
- (d) concentrating the expanded CAR T cell culture of (c);
- and
- (e) harvesting the concentrated CAR T cell culture of (d) to produce a genetically modified CAR T cell culture,
- wherein (a) through (e) are performed within a fully enclosed, automated cell engineering system, and the cell culture chamber has a fixed area;
- and
- wherein expansion of the transduced CAR T cell culture of (c) produces at least 20% more genetically modified CAR T cells than expansion utilizing manual cell culture with a flexible, gas permeable bag.
A method for automated production of a genetically modified T cell culture, the method comprising:
- (a) activating a T cell culture with an activation reagent selected from an antibody and a dendritic cell to produce an activated T cell culture;
- (b) transducing within a cell culture chamber the activated T cell culture with a viral vector encoding an ectodomain, a transmembrane domain and an endodomain, to produce a transduced T cell culture;
- (c) expanding within the cell culture chamber the transduced T cell culture;
- (d) concentrating the expanded T cell culture of (c);
- and
- (e) harvesting the concentrated T cell culture of (d) to produce a genetically modified T cell culture,
- wherein (a) through (e) are performed within a fully enclosed, automated cell engineering system, and the cell culture chamber has a fixed area;
- and
- wherein expansion of the transduced T cell culture in (c) produces at least 20% more genetically modified T cells than expansion utilizing manual cell culture with a flexible, gas permeable bag.
Dependencies are inferred from the claim text.