20250161457. Process Re (Regeneron Pharmaceuticals, .)
PROCESS FOR REDUCING SUBVISIBLE PARTICLES IN A PHARMACEUTICAL FORMULATION
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.
Inventor(s): Hanne BAK, John MATTILA, Ning LI, Xiaolin TANG, Daniel B. DIX, Chen LI, William MARKIS, Mayank PATEL
CPC Classification: A61K47/22 (PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms ; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles ; soap compositions ))
Search for rejections for patent application number 20250161457
- Patent Applications
- Regeneron Pharmaceuticals, Inc.
- CPC A61K47/22
- Hanne BAK of New York NY US
- John MATTILA of Nyack NY US
- Ning LI of New Canaan CT US
- Xiaolin TANG of Old Tappan NJ US
- Daniel B. DIX of LaGrangeville NY US
- Chen LI of Pleasantville NY US
- William MARKIS of Passaic NJ US
- Mayank PATEL of New City NY US