Process for reducing subvisible particles in a pharmaceutical formulation
US10342876B2 · kind B2 · utility
8Cited by
4References
21Claims
0Family size
Assignee
Inventors
Key dates
| Filing date | Oct 8, 2015 |
| Grant date | Jul 9, 2019 |
| Priority date | — |
| Expiry date | Aug 4, 2036 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K47/26
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.