Antibody formulations and methods

Abstract

Antibody formulations and methods useful for prophylaxis or treatment of amyloidosis, including AA amyloidosis and AL amyloidosis.

1 - 33 . (canceled) 
     
     
         34 . A nucleic acid comprising a nucleotide sequence encoding at least one polypeptide having an amino acid sequence set forth as any one of SEQ ID NOs: 13-16. 
     
     
         35 . The nucleic acid of  claim 34  comprising the nucleotide sequence of SEQ ID NO: 19. 
     
     
         36 . The nucleic acid of  claim 35  comprising the nucleotide sequence of SEQ ID NO: 20. 
     
     
         37 - 38 . (canceled) 
     
     
         39 . The nucleic acid of claim  38  comprising the nucleotide sequence of SEQ ID NO: 22. 
     
     
         40 . The nucleic acid of  claim 39  comprising the nucleotide sequence of SEQ ID NO: 23. 
     
     
         41 . A vector comprising at least one nucleic acid of  claim 34 . 
     
     
         42 . The vector of  claim 41 , comprising a nucleic acid comprising a nucleotide sequence encoding a polypeptide having an amino acid sequence set forth as SEQ ID NO: 13 and a nucleic acid comprising a nucleotide sequence encoding a polypeptide having an amino acid sequence set forth as SEQ ID NO: 15. 
     
     
         43 . The vector of  claim 41 , comprising a nucleic acid comprising a nucleotide sequence set forth as SEQ ID NO: 19 and a nucleic acid comprising a nucleotide sequence set forth as SEQ ID NO: 22. 
     
     
         44 . The vector of  claim 41 , comprising a nucleic acid comprising a nucleotide sequence set forth as SEQ ID NO: 20 and a nucleic acid comprising a nucleotide sequence set forth as SEQ ID NO: 23. 
     
     
         45 . A host cell comprising at least one nucleic acid of  claim 34  stably incorporated into its genome. 
     
     
         46 . The host cell of  claim 45 , wherein the host cell is a CHO cell. 
     
     
         47 . The host cell of  claim 45  having stably incorporated into its genome a nucleic acid comprising a nucleotide sequence encoding a polypeptide having an amino acid sequence set forth as SEQ ID NO: 13 and a nucleic acid comprising a nucleotide sequence encoding a polypeptide having an amino acid sequence set forth as SEQ ID NO: 15. 
     
     
         48 . The host cell of  claim 45  having stably incorporated into its genome a nucleic acid comprising a nucleotide sequence set forth as SEQ ID NO: 19 and a nucleic acid comprising a nucleotide sequence set forth as SEQ ID NO: 22. 
     
     
         49 . The host cell of  claim 45  having stably incorporated into its genome a nucleic acid comprising a nucleotide sequence set forth as SEQ ID NO: 20 and a nucleic acid comprising a nucleotide sequence set forth as SEQ ID NO: 23. 
     
     
         50 . The host cell of  claim 47 , wherein the host cell is a CHO cell. 
     
     
         51 . A method of making a pharmaceutical formulation comprising:
 (a) culturing mammalian cells having stably incorporated into their genome one or more nucleic acids encoding a light chain and a heavy chain of a humanized 2A4 antibody so that the mammalian cells secrete the antibody into cell culture media;   (b) purifying the antibody from the cell culture media; and   (c) preparing the pharmaceutical formulation.   
     
     
         52 . The method of  claim 51 , wherein the nucleic acid encoding the light chain of a humanized 2A4 antibody comprises a nucleotide sequence encoding a polypeptide having an amino acid sequence set forth as SEQ ID NO: 13, and wherein the nucleic acid encoding the heavy chain of a humanized 2A4 antibody comprises a nucleotide sequence encoding a polypeptide having an amino acid sequence set forth as any one of SEQ ID NOs: 14-16. 
     
     
         53 . The method of  claim 52 , wherein the nucleic acid encoding the light chain of a humanized 2A4 antibody comprises a nucleotide sequence encoding a polypeptide having an amino acid sequence set forth as SEQ ID NO: 13, and wherein the nucleic acid encoding the heavy chain of a humanized 2A4 antibody comprises a nucleotide sequence encoding a polypeptide having an amino acid sequence set forth as SEQ ID NO: 15. 
     
     
         54 . The method of  claim 53 , wherein the nucleic acid encoding the light chain of a humanized 2A4 antibody comprises a nucleotide sequence of SEQ ID NO: 19, and wherein the nucleic acid encoding the heavy chain of a humanized 2A4 antibody comprises a nucleotide sequence of SEQ ID NO: 22. 
     
     
         55 . The method of  claim 54 , wherein the nucleic acid encoding the light chain of a humanized 2A4 antibody comprises a nucleotide sequence of SEQ ID NO: 20, and wherein the nucleic acid encoding the heavy chain of a humanized 2A4 antibody comprises a nucleotide sequence of SEQ ID NO: 23. 
     
     
         56 - 86 . (canceled)