Lyophilization cycle development for a high-concentration monoclonal antibody formulation lacking a crystalline bulking agent

Journal of Pharmaceutical Sciences

Volumn 96, Issue 6, 2007, Pages 1598-1608

  Colandene, James D ^a   Maldonado, Linda M ^a   Creagh, Alma T ^a   Vrettos, John S ^a   Goad, Kenneth G ^a,b   Spitznagel, Thomas M ^a  

^a GLAXOSMITHKLINE   (United States)

^b Lilly Technology Center   (United States)

Author keywords

Calorimetry (DSC); Collapse; Freeze drying; FTIR; Glass transition; Lyophilization; Monoclonal antibody; Protein formulation; Proteins; Thermal analysis

Indexed keywords

BULKING AGENT; CITRATE SODIUM; GLYCINE; MANNITOL; MONOCLONAL ANTIBODY; POLYSORBATE 80; PROTEIN; SUCROSE;

ARTICLE; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DEGRADATION; DRUG FORMULATION; DRUG STABILITY; FREEZE DRYING; GLASS TRANSITION TEMPERATURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN CELL; INFRARED SPECTROSCOPY; PH MEASUREMENT; TEMPERATURE SENSITIVITY;

EID: 34250738378     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20812     Document Type: Article

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