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US 2015/0147317 A1Published application
Methods related to bevacizumab
AssigneeMomenta Pharmaceuticals, Inc.
InventorsJohn Robblee, Brian Edward Collins, Ganesh Kaundinya, Carlos J. Bosques
Life of this patent
Estimating the term…
Abstract
The present invention relates to the characterization and production of bevacizumab.
Claims21
1-28. (canceled)
A method of manufacturing a bevacizumab drug product, comprising:
- providing or obtaining a test glycoprotein preparation;
- acquiring at least one value for a bevacizumab parameter listed in Table 1 for the test glycoprotein preparation;
- and
- processing at least a portion of the test glycoprotein preparation as bevacizumab drug product if the at least one value for the test glycoprotein preparation meets a reference criterion shown in Table 1 for the parameter,
- thereby manufacturing a bevacizumab drug product.
2 more elements
A method of manufacturing a bevacizumab drug product, comprising:
- providing a host cell that is genetically engineered to express a first amino acid sequence having a sequence with at least about 85% identity to SEQ ID NO:1 (e.g., 90, 95, 98, or 100% identity to SEQ ID NO:1) and a second amino acid sequence having a sequence with at least about 85% identity to SEQ ID NO:2 (e.g., 90, 95, 98, or 100% identity to SEQ ID NO:2), wherein the expressed amino acid sequences form a recombinant antibody composition,
- culturing the host cell under conditions whereby the cell expresses the first and second amino acid sequences, wherein the expressed first and second amino acid sequences form recombinant antibodies,
- harvesting the recombinant antibodies from the host cell culture to produce an antibody preparation,
- acquiring a value for each parameter listed in Table 1 for the antibody preparation;
- and
- processing at least a portion of the antibody preparation into bevacizumab drug product if the value for each parameter listed in Table 1 for the antibody preparation meets the reference criterion shown in Table 1,
- thereby manufacturing a bevacizumab drug product.
4 more elements
Dependencies are inferred from the claim text.