Systematic investigation of the effect of lyophilizate collapse on pharmaceutically relevant proteins, part 2: Stability during storage at elevated temperatures

Journal of Pharmaceutical Sciences

Volumn 101, Issue 7, 2012, Pages 2288-2306

  Schersch, Kathrin ^a   Betz, Ortrud ^b   Garidel, Patrick ^b   Muehlau, Silke ^b   Bassarab, Stefan ^b   Winter, Gerhard ^a  

^a UNIVERSITY OF MUNICH   (Germany)

^b BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

Calorimetry (DSC); Collapse; Freeze drying; FTIR; l lactic dehydrogenase; Lyophilization; Monoclonal antibody; Protein aggregation; Protein formulation; Solid state stability

Indexed keywords

EXCIPIENT; IMMUNOGLOBULIN G; LACTATE DEHYDROGENASE; PLASMINOGEN ACTIVATOR; TREHALOSE; MANNITOL; SUCROSE; TISSUE PLASMINOGEN ACTIVATOR;

ARTICLE; CRYSTALLIZATION; FREEZE DRYING; GLASS TRANSITION TEMPERATURE; LYOPHILISATE; PH; PROTEIN AGGREGATION; PROTEIN CONFORMATION; PROTEIN STABILITY; STORAGE TEMPERATURE; ANIMAL; CHEMISTRY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG STORAGE; HEAT; INFRARED SPECTROSCOPY; METHODOLOGY; RABBIT; TRANSITION TEMPERATURE;

ANIMALS; CALORIMETRY, DIFFERENTIAL SCANNING; DRUG STORAGE; FREEZE DRYING; HOT TEMPERATURE; IMMUNOGLOBULIN G; L-LACTATE DEHYDROGENASE; MANNITOL; PROTEIN CONFORMATION; PROTEIN STABILITY; RABBITS; SPECTROSCOPY, FOURIER TRANSFORM INFRARED; SUCROSE; TISSUE PLASMINOGEN ACTIVATOR; TRANSITION TEMPERATURE; TREHALOSE;

EID: 84866293712     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23121     Document Type: Article

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