Pharmaceutical compositions of therapeutic proteins and methods of use
AssigneesGenentech, Inc., Hoffmann-La Roche Inc.
InventorsJunyan JI, Ellen Dorothee MEUX, Satya Krishna Kishore RAVURI, Karin SCHOENHAMMER, Jacqueline Yvonne TYLER, Ilona Elisabeth VOLLRATH, Adithi Chandrasekhara BHARGAVA, Jeremy Jean-Pierre DUBOEUF
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Abstract
The disclosure provides pharmaceutical compositions of therapeutic proteins and methods of using the same.
Claims63
A pharmaceutical composition comprising a therapeutic protein, polysorbate 20 (PS20), methionine, a buffering agent, and a carrier, wherein the molar ratio of the PS20 to the therapeutic protein is 100 or less, the PS20 is at a concentration from 0.01% to 0.12% weight-by-volume (w/v), the methionine is at a concentration from 1 mM to 50 mM, and the buffering agent is at a concentration from 5 mM to 20 mM.
5-14. (canceled)
16-36. (canceled)
A pharmaceutical composition comprising a bispecific antibody, a surfactant, methionine, and a carrier, wherein the pharmaceutical composition has a pH of about 5.5 or 5.8, and wherein:
- (i) the bispecific antibody comprises at least one antigen-binding domain that specifically binds to CD3 and at least one antigen-binding domain that specifically binds to a target antigen and wherein the bispecific antibody is at a concentration of about 10 mg/ml or less,
- (ii) the surfactant is at a concentration from about 0.05% to about 0.12% w/v, and
- (iii) the methionine is at a concentration of about 10 mM.
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43-57. (canceled)
59-64. (canceled)
A pharmaceutical composition comprising a bispecific antibody, PS20, methionine, a buffering agent, and a carrier, wherein the molar ratio of the PS20 to the bispecific antibody is about 100 or less, the PS20 is at a concentration from about 0.01% to about 0.12% w/v, the methionine is at a concentration from 1 mM to 50 mM, and the buffering agent is at a concentration from 5 mM to 20 mM, wherein the bispecific antibody comprises an anti-CD3 arm and an anti-FcRH5 arm, and wherein:
- (a) the anti-CD3 arm comprises a CD3-binding domain comprising:
- an HVR-H1 comprising the amino acid sequence of SEQ ID NO:
- 65;
- an HVR-H2 comprising the amino acid sequence of SEQ ID NO:
- 66;
- an HVR-H3 comprising the amino acid sequence of SEQ ID NO:
- 67;
- an HVR-L1 comprising the amino acid sequence of SEQ ID NO:
- 68;
- an HVR-L2 comprising the amino acid sequence of SEQ ID NO:
- 69;
- and
- an HVR-L3 comprising the amino acid sequence of SEQ ID NO:
- 70;
- and
- (b) the anti-FcRH5 arm comprises a FcRH5-binding domain comprising:
- an HVR-H1 comprising the amino acid sequence of SEQ ID NO:
- 57;
- an HVR-H2 comprising the amino acid sequence of SEQ ID NO:
- 58;
- an HVR-H3 comprising the amino acid sequence of SEQ ID NO:
- 59;
- an HVR-L1 comprising the amino acid sequence of SEQ ID NO:
- 60;
- an HVR-L2 comprising the amino acid sequence of SEQ ID NO:
- 61;
- and
- an HVR-L3 comprising the amino acid sequence of SEQ ID NO:
- 62.
68-74. (canceled)
A pharmaceutical composition comprising a bispecific antibody, PS20, methionine, a buffering agent, and a carrier, wherein the molar ratio of the PS20 to the bispecific antibody is about 100 or less, the PS20 is at a concentration from about 0.01% to about 0.12% w/v, the methionine is at a concentration from 1 mM to 50 mM, and the buffering agent is at a concentration from 5 mM to 20 mM, wherein the bispecific antibody comprises an anti-CD3 arm and an anti-HER2 arm, and wherein:
- (a) the anti-CD3 arm comprises a CD3-binding domain comprising:
- an HVR-H1 comprising the amino acid sequence of SEQ ID NO:
- 109;
- an HVR-H2 comprising the amino acid sequence of SEQ ID NO:
- 110;
- an HVR-H3 comprising the amino acid sequence of SEQ ID NO:
- 111;
- an HVR-L1 comprising the amino acid sequence of SEQ ID NO:
- 112;
- an HVR-L2 comprising the amino acid sequence of SEQ ID NO:
- 113;
- and
- an HVR-L3 comprising the amino acid sequence of SEQ ID NO:
- 114;
- and
- (b) the anti-HER2 arm comprises a HER2-binding domain comprising:
- an HVR-H1 comprising the amino acid sequence of SEQ ID NO:
- 93;
- an HVR-H2 comprising the amino acid sequence of SEQ ID NO:
- 94;
- an HVR-H3 comprising the amino acid sequence of SEQ ID NO:
- 95;
- an HVR-L1 comprising the amino acid sequence of SEQ ID NO:
- 96;
- an HVR-L2 comprising the amino acid sequence of SEQ ID NO:
- 97;
- and
- an HVR-L3 comprising the amino acid sequence of SEQ ID NO:
- 98.
83-84. (canceled)
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94-95. (canceled)
98-105. (canceled)
107-108. (canceled)
110-112. (canceled)
115-119. (canceled)
124-131. (canceled)
133-152. (canceled)
157-158. (canceled)
Dependencies are inferred from the claim text.