Systematic investigation of the effect of lyophilizate collapse on pharmaceutically relevant proteins I: Stability after freeze-drying

Journal of Pharmaceutical Sciences

Volumn 99, Issue 5, 2010, Pages 2256-2278

  Schersch, K ^a   Betz, O ^b   Garidel, P ^b   Muehlau, S ^b   Bassarab, S ^b   Winter, G ^a  

^a UNIVERSITY OF MUNICH   (Germany)

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

Author keywords

Calorimetry (DSC); Collapse; Freeze drying lyophilization; FTIR; L lactic dehydrogenase; Monoclonal antibody; Protein aggregation; Protein formulation; Solid state stability; Specific surface area

Indexed keywords

CRYSTALLIN; EXCIPIENT; GLASS; IMMUNOGLOBULIN G1 ANTIBODY; LACTATE DEHYDROGENASE; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY PA 01; PA 01; PROTEIN; UNCLASSIFIED DRUG;

ANALYTIC METHOD; ARTICLE; CONTROLLED STUDY; CRYSTALLIZATION; DRUG FORMULATION; DRUG SOLUBILITY; DRUG STABILITY; FREEZE DRYING; LYOPHILISATE; MOISTURE; PROTEIN AGGREGATION; PROTEIN CONFORMATION; PROTEIN STABILITY; SENSITIVITY ANALYSIS; SPECIFIC SURFACE AREA; SURFACE PROPERTY; TEMPERATURE SENSITIVITY;

EID: 77951261150     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22000     Document Type: Article

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