Effect of moisture on the stability of a lyophilized humanized monoclonal antibody formulation

Pharmaceutical Research

Volumn 18, Issue 9, 2001, Pages 1345-1353

  Breen, E D ^a   Curley, J G ^a   Overcashier, D E ^a   Hsu, C C ^a   Shire, S J ^a  

^a GENENTECH INC   (United States)

Author keywords

Aggregation; Asp isomerization; Glass transition temperature; Modulated DSC; Protein stability

Indexed keywords

HISTIDINE; HUMAN MONOCLONAL ANTIBODY; POLYSORBATE; SUCROSE;

ANTIBODY PRODUCTION; ANTIBODY STRUCTURE; ARTICLE; CHROMATOGRAPHY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG FORMULATION; DRUG STABILITY; FREEZE DRYING; GEL PERMEATION CHROMATOGRAPHY; HUMAN; INFRARED SPECTROSCOPY; ISOMERISM; MATHEMATICAL MODEL; MOISTURE; PRIORITY JOURNAL; PROTEIN AGGREGATION; PROTEIN DEGRADATION; PROTEIN SECONDARY STRUCTURE; PROTEIN STABILITY; TEMPERATURE DEPENDENCE; THERMOSTABILITY;

ANTIBODIES, MONOCLONAL; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHYSICAL; CHROMATOGRAPHY, GEL; COLOR; DRUG STABILITY; DRUG STORAGE; ELECTROPHORESIS, POLYACRYLAMIDE GEL; FREEZE DRYING; HUMANS; HUMIDITY; HYDROLYSIS; NEPHELOMETRY AND TURBIDIMETRY; OXIDATION-REDUCTION; PAPAIN; PEPSIN A; SPECTROSCOPY, FOURIER TRANSFORM INFRARED;

EID: 0034854492     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1013054431517     Document Type: Article

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