Method for reducing immunogenicity of therapeutic protein compositions
US8697848B2 · kind B2 · utility
Assignees
Inventors
Key dates
| Filing date | Jul 19, 2011 |
| Grant date | Apr 15, 2014 |
| Priority date | — |
| Expiry date | Jul 21, 2031 |
Classification
- Technology area (CPC C)Chemistry; Metallurgy
- CPC primaryC07K2317/21
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
The present invention provides methods for reducing and/or evaluating the immunogenic potential of a therapeutic protein preparation. The present invention further provides pharmaceutical compositions of therapeutic proteins and methods of treatment with the same, the compositions having low immunogenic potential and/or improved efficacy. The invention achieves these goals by evaluating therapeutic protein preparations for subvisible protein particulates, which can contribute significantly to the overall immunogenic potential of the protein preparation. Further, by maintaining the content of such subvisible protein particulates to below an immunogenic threshold level, the resulting pharmaceutical composition is less likely to result in a loss of tolerance (e.g., upon repeated administration), thereby improving both the safety and efficacy profile of the therapeutic.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.