Composition comprising antibody that binds to domain II of HER2 and acidic variants thereof
AssigneeGenentech, Inc.
InventorsReed J Harris, Paul A. Motchnick
Life of this patent
Estimating the term…
Abstract
A composition comprising a main species HER2 antibody that binds to domain II of HER2 and acidic variants thereof is described. Pharmaceutical formulations comprising the composition, and therapeutic uses for the composition are also disclosed.
Claims30
A method of making a pharmaceutical formulation comprising combining:
- (i) a composition comprising:
- (a) a main species HER2 antibody comprising light chain and heavy chain amino acid sequences set forth in SEQ ID Nos. 15 and 16, respectively;
- and
- (b) acidic variants of the main species antibody, comprising a disulfide reduced variant, with:
- (ii) a pharmaceutically acceptable carrier.
A method of making a pharmaceutical composition comprising preparing a composition comprising a main species HER2 antibody comprising light chain and heavy chain amino acid sequences set forth in SEQ ID Nos. 15 and 16, respectively, and acidic variants of the main species antibody, comprising a disulfide reduced variant, wherein the disulfide reduced variant comprises 1% to 6% of the composition, when measured by non-reduced CE-SDS.
A method of making a pharmaceutical formulation comprising combining:
- (i) a composition comprising:
- (a) a main species HER2 antibody comprising light chain and heavy chain amino acid sequences set forth in SEQ ID Nos. 15 and 16, respectively;
- and
- (b) variants that elute earlier than the main species antibody upon separation by cation exchange chromatography, the variants comprising a disulfide reduced variant, with:
- (ii) a pharmaceutically acceptable carrier.
A method of making a pharmaceutical composition comprising preparing a composition comprising a main species HER2 antibody comprising light chain and heavy chain amino acid sequences set forth in SEQ ID Nos. 15 and 16, respectively, and variants that elute earlier than the main species antibody upon separation by cation exchange chromatography, the variants comprising disulfide reduced variant, glycated variant, deamidated variant, sialylated variant, and non-reducible variant constituting at least 75 to 80% of the acidic variants in the composition.
Dependencies are inferred from the claim text.