Antibody formulations and methods
Antibody formulations and methods useful for prophylaxis or treatment of amyloidosis, including AA amyloidosis and AL amyloidosis.
1. A lyophilized formulation of an antibody, comprising about:
(a) 500 mg of a humanized version of antibody 2A4 (ATCC Accession Number PTA-9662) or antibody 7D8 (ATCC Accession Number PTA-9468) or antigen binding fragment thereof;
(b) 27.2 mg histidine;
(c) 15.7 mg L-histidine HCl monohydrate;
(d) 870.2 mg trehalose; and
(e) 2.0 mg polysorbate 20.
2. A lyophilized formulation of an antibody, comprising: (a) a humanized version of antibody 2A4 (ATCC Accession Number PTA-9662) or antibody 7D8 (ATCC Accession Number PTA-9468) or antigen binding fragment thereof; (b) L-histidine; (c) L-histidine HCl monohydrate; (d) trehalose; and (e) polysorbate 20 reconstitutable to an aqueous solution wherein: (i) the antibody is present at a concentration of about 50 mg/mL; (ii) a histidine buffer is present at a concentration of about 25 mM; (iii) the trehalose is present at a concentration of about 230 mM; (iv) the polysorbate 20 is present at a concentration of about 0.2 g/L; and wherein the solution has a pH of about 6.5.
3. The lyophilized formulation of claim 1 , wherein the antibody comprises a light chain variable region comprising three complementarity determining regions set forth as SEQ ID NOs: 6, 7, and 8, and a heavy chain variable region comprising three complementarity regions set forth as SEQ ID NOs: 9, 10, and 11.
4. The lyophilized formulation of claim 2 , wherein the antibody comprises a light chain variable region comprising three complementarity determining regions set forth as SEQ ID NOs: 6, 7, and 8, and a heavy chain variable region comprising three complementarity regions set forth as SEQ ID NOs: 9, 10, and 11.
5. The lyophilized formulation of claim 2 , wherein the antibody comprises a light chain variable region comprising three complementarity determining regions set forth as SEQ ID NOs: 12, 7, and 8, and a heavy chain variable region comprising three complementarity regions set forth as SEQ ID NOs: 9, 10, and 11.
6. The lyophilized formulation of claim 1 , wherein the antibody comprises a light chain variable region comprising an amino acid sequence set forth as SEQ ID NO: 4 and a heavy chain variable region comprising an amino acid sequence set forth as SEQ ID NO: 5.
7. The lyophilized formulation of claim 2 , wherein the antibody comprises a light chain variable region comprising an amino acid sequence set forth as SEQ ID NO: 4 and a heavy chain variable region comprising an amino acid sequence set forth as SEQ ID NO: 5.
8. The lyophilized formulation of claim 2 , wherein the antibody comprises a light chain comprising an amino acid sequence set forth as SEQ ID NO: 13 and a heavy chain comprising an amino acid sequence set forth as any one of SEQ ID NOs: 14-16.
9. The lyophilized formulation of claim 2 , wherein the antibody comprises a light chain comprising an amino acid sequence set forth as SEQ ID NO: 13 and a heavy chain comprising an amino acid sequence set forth as SEQ ID NO: 15.