Crystalline anti-hTNFalpha antibodies
AssigneeAbbVie Biotechnology Ltd.
InventorsAnette Koenigsdorfer, Stefan Gottschalk, Hans-Juergen Krause, Gerhard Winter, David W. Borhani, Wolfgang Fraunhofer
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Abstract
The present invention relates to a batch crystallization method for crystallizing an anti-hTNFalpha antibody which allows the production of said antibody on an industrial scale; antibody crystals as obtained according to said method; compositions containing said crystals as well as methods of use of said crystals and compositions.
Claims21
A method for treating a TNFalpha-related disorder in a subject in need thereof, said method comprising the step of administering to the subject an effective amount of anti-hTNFalpha antibody crystals,
- wherein the antibody is an isolated human IgG antibody comprising two heavy chains each with a molecular weight of about 50 kpa, a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:
- 1, and a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:
- 2, and
- wherein the crystals have a needle-like morphology with a length 1 of about 2-500 μm and an 1/d ratio of about 3 to 30.
A method for treating a TNFalpha-related disorder in a subject in need thereof, said method comprising the step of administering to the subject an effective amount of a pharmaceutical composition comprising:
- (a) crystals of an isolated human IgG anti-hTNFalpha antibody, wherein the antibody comprises two heavy chains each with a molecular weight of about 50 kpa, a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:
- 1, and a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:
- 2, and wherein the crystals have a needle-like morphology with a length 1 of about 2-500 μm and an 1/d ratio of about 3 to 30, and
- (b) a pharmaceutical excipient.
Dependencies are inferred from the claim text.