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US 2021/0002384 A1Published application
Process for producing hu14.18k322a monoclonal antibody
AssigneeSt. Jude Children's Research Hospital
InventorsMichael M. Meagher, Muralidhar Reddivari
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Abstract
A fed-batch process for producing Hu14.18K322A monoclonal antibody by culturing a mammalian cell culture in a culture medium including plant protein hydrolysates and a stable glucose concentration is provided, wherein said method yields a population of Hu14.18K322A monoclonal antibodies with increased titer and percentage of afucosylation.
Claims12
1:
- A fed-batch process for producing Hu14.18K322A monoclonal antibody in mammalian host cell culture comprising culturing mammalian host cells, which harbor a nucleic acid encoding Hu14.18K322A monoclonal antibody and are selected for producing substantially afucosylated Hu14.18K322A monoclonal antibody, in a cell culture medium comprising plant protein hydrolysates and a stable glucose concentration of 0.5 g/L to 1.5 g/L, thereby producing Hu14.18K322A monoclonal antibody in mammalian cell culture.
2:
- The fed-batch process of claim 1, further comprising the step of purifying the Hu14.18K322A monoclonal antibody.
3:
- The fed-batch process of claim 2, wherein the Hu14.18K322A monoclonal antibody is purified by contacting the cell culture medium comprising the Hu14.18K322A monoclonal antibody with a protein A resin and eluting the Hu14.18K322A monoclonal antibody.
4:
- The fed-batch process of claim 1, wherein the Hu14.18K322A monoclonal antibody is at least 55% afucosylated.
5:
- A population of substantially afucosylated Hu14.18K322A monoclonal antibodies produced by the method of claim 1.
6:
- The population of substantially afucosylated Hu14.18K322A monoclonal antibodies of claim 5, wherein said antibodies are at least 55% afucosylated.
7:
- The population of Hu14.18K322A monoclonal antibodies of claim 5, wherein said population has an antibody titer of at least about 400 mg/L.
8:
- The population of Hu14.18K322A monoclonal antibodies of claim 5, wherein said Hu14.18K322A monoclonal antibodies exhibit enhanced ADCC activity.
9:
- A pharmaceutical composition comprising the population of Hu14.18K322A monoclonal antibodies of claim 5 in admixture with a physiologically acceptable diluent, carrier, or excipient.
10:
- A mammalian host cell harboring a nucleic acid encoding Hu14.18K322A monoclonal antibody and selected for producing substantially afucosylated Hu14.18K322A monoclonal antibody.
11:
- The mammalian host cell of claim 10, wherein said antibody is at least 55% afucosylated.
12:
- A mammalian host cell deposited under American Type Culture Collection accession number PTA-125712 on Feb. 13, 2019.