Protein formulation comprising coagulation factor VIII or factor IX in an aqueous solution
US5919908A · kind A · utility
Assignee
Inventors
Key dates
| Filing date | Nov 26, 1997 |
| Grant date | Jul 6, 1999 |
| Priority date | — |
| Expiry date | Nov 26, 2017 |
Classification
- Technology area (CPC Y)Emerging Cross-Sectional Technologies
- CPC primaryY10S530/83
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
A final drug product comprises a plasma protein selected from the group consisting of coagulation factor VIII and factor IX, in an aqueous solution. The concentration of oxygen in the solution is reduced and/or the solution contains an antioxidant. The solution further contains a carbohydrate in a concentration of at least 350 mg/ml. The protein activity after storage for at least 6 months at a temperature of from 0.degree. C. to 40.degree. C. is from 70% to 130% of its initial value. In a process for preparing the final drug product and a method for improving the long-term stability of coagulation factor VIII or factor IX in an aqueous solution, a carbohydrate is included in the solution in a concentration of at least 350 mg/ml and the solution is stored in its final container under an oxygen-reduced atmosphere or includes an antioxidant.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.