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US 10,328,148 B2Granted
Protein drug formulations and packages
AssigneePurdue Research Foundation
InventorsElizabeth Murphy Topp, Frederick E. Regnier, Jun Zhang
Life of this patent
Estimating the term…
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 poly amino acid ligands of the protein drug.
Claims20
A pharmaceutical composition suitable for delivery to a patient comprising:
- a mixed human IgG having an Fc domain;
- and
- a protein A fragment consisting of sequences selected from the group consisting of FNKEQQNAFYEIL (SEQ ID NO:3) and EQRNGFIQSLKD (SEQ ID NO:4), wherein the mixed human IgG is bound to the protein A fragment via the Fc domain and is substantially free of IgG aggregates, wherein the ratio of mixed human IgG to the protein A fragment is approximately 1:4.
A pharmaceutical composition comprising:
- a protein drug having an Fc domain;
- and
- a polyamino acid ligand consisting of FNKEQQNAFYEIL (SEQ ID NO:3), or a polyamino acid ligand consisting of EQRNGFIQSLKD (SEQ ID NO:4), wherein the ratio of the protein drug to the polyamino acid ligand is approximately 1:4 wherein the polyamino acid ligand is bound to the Fc domain of the protein drug and the protein drug exhibits reduced aggregation as compared to the protein drug alone.
A pharmaceutical composition comprising:
- a protein drug having an Fc domain;
- and
- a polypeptide consisting of 13 to 50 amino acids that comprises a polyamino acid ligand consisting of FNKEQQNAFYEIL (SEQ ID NO:3),
- wherein the ratio of the protein drug to the polyamino acid ligand is approximately 1:4, wherein the polyamino acid ligand is bound to the Fc domain of the protein drug, and wherein the protein drug exhibits reduced aggregation as compared to the protein drug alone.
1 more element
A pharmaceutical composition comprising:
- a protein drug having an Fc domain;
- and
- a polypeptide consisting of 12 to 50 amino acids that comprises a polyamino acid ligand consisting of EQRNGFIQSLKD (SEQ ID NO:4),
- wherein the ratio of the protein drug to the polyamino acid ligand is approximately 1:4, wherein the polyamino acid ligand is bound to the Fc domain of the protein drug, and wherein the protein drug exhibits reduced aggregation as compared to the protein drug alone.
1 more element
A method of stabilizing a protein drug, the method comprising:
- contacting a free protein drug having an Fc domain with a free polyamino acid ligand that binds to the Fc domain, wherein the ratio of protein drug to the polyamino acid ligand is approximately 1:4, thereby creating a stabilized protein drug exhibiting a reduced formation of aggregates as compared to the free protein drug, wherein said polyamino acid ligand consists of sequences selected from the group consisting of SEQ ID NO:3 and SEQ ID NO:4.
A method of stabilizing a protein drug, the method comprising:
- contacting a free protein drug having an Fc domain with a free polypeptide consisting of 13 to 50 amino acids that comprises a polyamino acid ligand consisting of FNKEQQNAFYEIL (SEQ ID NO:3), or
- contacting a free protein drug having an Fc domain with a free polypeptide consisting of 12 to 50 amino acids that comprises a polyamino acid ligand consisting of EQRNGFIQSLKD (SEQ ID NO:4),
- wherein the polyamino acid ligand binds to the Fc domain, and wherein the ratio of protein drug to the polyamino acid ligand is approximately 1:4, thereby creating a stabilized protein drug exhibiting a reduced formation of aggregates as compared to the free protein drug alone.
A pharmaceutical composition suitable for long term storage comprising:
- a protein drug having an Fc domain;
- and
- a polyamino acid ligand comprising an epitope sequence of FNKEQQNAFYEIL (SEQ ID NO:3), or a polyamino acid ligand comprising an epitope sequence of EQRNGFIQSLKD (SEQ ID NO:4), wherein the polyamino acid ligand is further releasably embedded in a polymer backbone and bound to the Fc domain of the protein drug.
Dependencies are inferred from the claim text.