Protein drug formulations and packages

Abstract

Compositions and methods that include stabilized protein drugs are described. In addition, protein drug formulations that are more stable under ambient conditions are described. The formulations include one or more polyamino acid ligands of the protein drug.

1 . A pharmaceutical composition comprising a protein drug, where the protein drug includes an Fcc domain; and one or more polyamino acid ligands for the protein. 
     
     
         2 . The composition of  claim 1  wherein the protein is selected from the group consisting of IgG1, IgG2 and an immunoglobulin G-like protein; and
 the polyamino acid ligand is selected from the group consisting of protein A, protein G, protein A/G and a fragment, analog or derivative of protein A, protein G or protein A/G. 
 
     
     
         3 - 13 . (canceled) 
     
     
         14 . The composition of  claim 2  wherein at least one ligand comprises domain B of protein A. 
     
     
         15 . The composition of  claim 2  wherein at least one ligand is protein G. 
     
     
         16 . The composition of  claim 2  wherein at least one ligand comprises domain II of protein G. 
     
     
         17 . The composition of  claim 2  wherein at least one ligand comprises the peptide FNKXQQX1AFYX2X3L (SEQ ID NO: 1), where X, X1, X2, and X3 are naturally occurring amino acids or derivatives thereof. 
     
     
         18 . The composition of  claim 2  wherein at least one ligand comprises the peptide X4QRNGFIQSLKD (SEQ ID NO: 2), where X4 is a naturally occurring amino acid or a derivative thereof. 
     
     
         19 . The composition of  claim 2  wherein at least one ligand comprises the peptide FNKXQQX1AFYX2X3L (SEQ ID NO: 1) and the peptide X4QRNGFIQSLKD (SEQ ID NO: 2), where X, X1, X2, X3, and X4 are naturally occurring amino acids or derivatives thereof. 
     
     
         20 . (canceled) 
     
     
         21 . The composition of  claim 19  wherein FNKXQQX1AFYX2X3L (SEQ ID NO: 1) and X4QRNGFIQSLKD (SEQ ID NO: 2) are covalently attached through a linker, where X, X1, X2, X3, and X4 are naturally occurring amino acids or derivatives thereof. 
     
     
         22 . The composition of  claim 21  wherein
 a) X is E or D; or 
 b) X1 is N or S; or 
 c) X2 is E or Q; or 
 d) X3 is I or V; or 
 e) X4 is E, D, or A or 
 f) any combination of a-e. 
 
     
     
         23 - 26 . (canceled) 
     
     
         27 . The composition of  claim 2  wherein at least one ligand comprises the peptide FNKEQQNAFYEIL (SEQ ID NO: 3). 
     
     
         28 . The composition of  claim 2  wherein at least one ligand comprises the peptide EQRNGFIQSLKD (SEQ ID NO: 4). 
     
     
         29 . (canceled) 
     
     
         30 . (canceled) 
     
     
         31 . The composition of  claim 2  wherein at least one ligand comprises the peptide FNKEQQNAFYEIL (SEQ ID NO: 3) and the peptide EQRNGFIQSLKD (SEQ ID NO: 4) covalently attached through a linker. 
     
     
         32 . The composition of  claim 31  wherein the linker is a linking peptide, wherein said linking peptide comprising a polyaspartamide or a poly(ethylene oxide). 
     
     
         33 - 35 . (canceled) 
     
     
         36 . The pharmaceutical composition of  claim 2  comprising two or more polyamino acid ligands for the protein. 
     
     
         37 - 39 . (canceled) 
     
     
         40 . The composition of  claim 2  wherein the ligand is attached to a solid support. 
     
     
         41 - 47 . (canceled) 
     
     
         48 . A kit comprising a solid support, a composition of  claim 2 , a releasing agent, and a set of instructions for preparing a formulation for administering to a patient; wherein the composition is attached to the support; and where the releasing agent is capable of removing the protein drug from the solid support when placed in contact with the composition attached to the solid support. 
     
     
         49 . The kit of  claim 48  wherein
 a) the solid support comprises an amino modified glass formed as a sterile glass vial or a sterile glass syringe; and 
 b) the releasing agent comprises an agent selected form the group consisting of a glycine buffer, protein A, protein G, proteinA/G, a fragment of protein A, protein G or proteinA/G and an acid or an acidic buffer. 
 
     
     
         50 - 56 . (canceled) 
     
     
         57 . A pharmaceutical composition comprising a protein drug and a polyamino acid ligand for the protein, wherein the protein drug includes an Fcc domain and said polyamino acid ligand is selected from the group consisting of protein G, protein A/G, a fragment, analog or derivative of protein G or protein A/G, a peptide comprising the sequence FNKEQQNAFYEIL (SEQ ID NO: 3), and a peptide comprising the sequence X4QRNGFIQSLKD (SEQ ID NO: 2), wherein X4 is E, D, or A. 
     
     
         58 . The pharmaceutical composition of  claim 57  wherein the protein drug is an immunoglobulin.