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.
Claims52
A method for automated production of a genetically modified immune cell culture, the method comprising:
- (a) activating an immune cell culture with an activation reagent to produce an activated immune cell culture;
- (b) transducing the activated immune cell culture with a vector, to produce a transduced immune cell culture;
- (c) expanding the transduced immune cell culture;
- (d) concentrating the expanded immune cell culture of (c);
- and
- (e) harvesting the concentrated immune cell culture of (d) to produce a genetically modified immune cell culture,
- further comprising washing either or both the expanded immune cell culture and the concentrated immune cell culture,
- wherein (a) through (e) are performed by a fully enclosed cell engineering system and (a) through (e) are optimized via a process to produce the genetically modified immune cell culture.
(canceled)
7-16. (canceled)
18-20. (canceled)
23-27. (canceled)
29-30. (canceled)
A method for promoting a preferred phenotype of a genetically modified immune cell culture, the method comprising:
- (a) activating an immune cell culture with an activation reagent to produce an activated immune cell culture, wherein the activation reagent and activating conditions promote the phenotype of the genetically modified immune cell culture;
- (b) transducing the activated immune cell culture with a vector, to produce a transduced immune cell culture;
- (c) expanding the transduced immune cell culture;
- (d) concentrating the expanded immune cell culture of (c);
- and
- (e) harvesting the concentrated immune cell culture of (d) to produce a genetically modified immune cell culture,
- wherein (a) through (e) are performed by a fully enclosed, automated cell engineering system.
32-62. (canceled)
The method of claim 96,
- wherein each of (a) through (e) are performed with immune cell cultures having an optimized cell density (cells/mL) and an optimized cell confluency (cells/cm2).
64-95. (canceled)
A method for automated production of a genetically modified immune cell culture, the method comprising:
- (a) activating an immune cell culture with an activation reagent to produce an activated immune cell culture;
- (b) transducing the activated immune cell culture with a vector, to produce a transduced immune cell culture;
- (c) expanding the transduced immune cell culture, wherein the transduced cell culture is not shaken during the expanding;
- (d) concentrating the expanded immune cell culture of (c);
- and
- (e) harvesting the concentrated immune cell culture of (d) to produce a genetically modified immune cell culture,
- wherein (a) through (e) are performed by a fully enclosed, automated cell engineering system.
(canceled)
A method for automated production of a genetically modified immune cell culture, the method performed by a cell engineering system, comprising:
- (a) activating an immune cell culture with an activation reagent to produce an activated immune cell culture in a first chamber of the cell engineering system;
- (b) transducing the activated immune cell culture, the transducing comprising:
- i. transferring the activated immune cell culture from the first chamber to an electroporation unit;
- ii. electroporating the activated immune cell culture with a vector, to produce a transduced immune cell culture;
- iii. transferring the transduced immune cell culture to a second chamber of the cell engineering system;
- (c) expanding the transduced immune cell culture;
- (d) concentrating the expanded immune cell culture of (c);
- and
- (e) harvesting the concentrated immune cell culture of (d) to produce a genetically modified cell culture.
127-156. (canceled)
A cassette for use in an automated cell engineering system, comprising:
- (a) a low temperature chamber, for storage of a cell culture media;
- (b) a high temperature chamber for carrying out activation, transduction and expansion of an immune cell culture,
- wherein the high temperature chamber is separated from the low temperature chamber, by a thermal barrier,
- the high temperature chamber including a cell culture chamber;
- and
- (c) one or more fluidics pathways connected to the cell culture chamber, wherein the fluidics pathways provide recirculation, removal of waste and homogenous gas exchange and distribution of nutrients to the cell culture chamber without disturbing cells within the cell culture chamber.
158-180. (canceled)
Dependencies are inferred from the claim text.