Mannitol hemihydrate in lyophilized protein formulations: Impact of its dehydration during storage on sucrose crystallinity and protein stability
Jayesh Sonje, Seema Thakral, Brendan M. Mayhugh, Gregory A. Sacha, Steve Nail, Jayasree Srinivasan, Raj Suryanarayanan
Topics & Concepts
MannitolSucroseChemistryCrystallizationDehydrationFreeze-dryingExcipientCrystallinityRelative humidityDifferential scanning calorimetryChromatographyBovine serum albuminAmorphous solidBiochemistryOrganic chemistryCrystallographyPhysicsThermodynamicsProtein purification and stabilityMicroencapsulation and Drying ProcessesMicrobial Inactivation Methods