Methods of manufacturing therapeutic proteins
AssigneesMomenta Pharmaceuticals, Inc., Biofactura, Inc.
InventorsRasheed TIJANI, Darryl Bacon SAMPEY, John ROBBLEE, Gan WEI, Chaomei HE
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Abstract
Disclosed herein are methods of manufacturing therapeutic proteins.
Claims42
A method of manufacturing a therapeutic protein, the method comprising:
- culturing a cholesterol-auxotrophic and glutamine-auxotrophic cell;
- transfecting the cell with (i) a nucleic acid encoding a protein which is capable of restoring cholesterol biosynthesis in the cell;
- (ii) a nucleic acid encoding a protein which is capable of restoring glutamine biosynthesis in the cell;
- and (iii) a nucleic acid or nucleic acids encoding the therapeutic protein;
- culturing the cell under conditions suitable for expression of the therapeutic protein;
- and
- isolating and/or purifying the therapeutic protein.
The method of any preceding claim, wherein the cell is cultured (e.g., after transfection of nucleic acid (i)) in the absence of exogenously introduced cholesterol.
The method of any preceding claim, wherein the cell is cultured (e.g., after transfection of nucleic acid (ii)) in the absence of exogenously introduced glutamine.
The method of any preceding claim, wherein the cell is an NS0 cell.
The method of any preceding claim, wherein the protein is selected from the group consisting of adalimumab, infiliximab, palivizumab, cetuximab, natalizumab, eculizumab, ustekinumab, golimumab, ofatumab, canakinumab, belimumab, alirocumab, mepolizumab, necitumumab, nivolumab, dinutuximab, secukinumab, evolocumab, blinatumomab, pembrolizumab, ramucirumab, vedolizumab, siltuximab, obinutuzumab, trastuzumab, raxibacumab, pertuzumab, brentuximab, ipilimumab, denosumab, tocilizumab, ofatumumab, canakinumab, certolizumab, catumaxomab, ranibizumab, panitumumab, bevacizumab, cetuximab, efalizumab, omalizumab, tositumomab, ibritumomab, alemtuzumab, gemtuzumab, basiliximab, daclizumab, rituximab, abciximab, alefacept, entanercept, abatacept, belatacept, aflibercept, ziv-aflibercept, rilonacept, romiplostim, apocept, trebananib, blisibimod, and dulaglutide.
A method of manufacturing a therapeutic protein, the method comprising:
- culturing a cholesterol-auxotrophic;
- transfecting the cell with (i) a nucleic acid encoding a protein which is capable of restoring cholesterol biosynthesis in the cell;
- (ii) a nucleic acid encoding a protein expressing one or more selectable marker;
- and (iii) a nucleic acid or nucleic acids encoding the therapeutic protein;
- culturing the cell under conditions suitable for expression of the therapeutic protein;
- and
- isolating and/or purifying the therapeutic protein.
A method of manufacturing a therapeutic protein, the method comprising:
- culturing a cholesterol-auxotrophic;
- transfecting the cell with (i) a nucleic acid encoding a protein which is capable of restoring cholesterol biosynthesis in the cell;
- (ii) a nucleic acid encoding a protein expressing a first selectable marker;
- (iii) a nucleic acid encoding a protein expressing a second selectable marker and (iv) a nucleic acid or nucleic acids encoding the therapeutic protein;
- culturing the cell under conditions suitable for expression of the therapeutic protein;
- and
- isolating and/or purifying the therapeutic protein.
Dependencies are inferred from the claim text.