Process for reducing subvisible particles in a pharmaceutical formulation
US12070502B2 · kind B2 · utility
0Cited by
114References
48Claims
0Family size
Assignee
Inventors
Key dates
| Filing date | Apr 8, 2019 |
| Grant date | Aug 27, 2024 |
| Priority date | — |
| Expiry date | Apr 8, 2039 |
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.