Predicting accelerated aggregation rates for monoclonal antibody formulations, and challenges for low-temperature predictions

Journal of Pharmaceutical Sciences

Volumn 100, Issue 10, 2011, Pages 4234-4243

  Brummitt, Rebecca K ^a,c   Nesta, Douglas P ^b   Roberts, Christopher J ^a  

^a University of Delaware   (United States)

^b GLAXOSMITHKLINE   (United States)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Biotechnology; Kinetics; Protein aggregation; Proteins; Stability

Indexed keywords

MONOCLONAL ANTIBODY; MONOMER; SODIUM CHLORIDE; PROTEIN AGGREGATE;

ARTICLE; DRUG FORMULATION; HALF LIFE TIME; HIGH TEMPERATURE; KINETICS; LOW TEMPERATURE; PH; PROTEIN AGGREGATION; PROTEIN UNFOLDING; QUANTITATIVE STUDY; SHELF LIFE; TEMPERATURE; THERMOGRAPHY; CHEMICAL MODEL; CHEMISTRY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG STABILITY; DRUG STORAGE; MEDICINAL CHEMISTRY; PARTICLE SIZE; PHARMACEUTICS; PROCEDURES; PROTEIN STABILITY; SIZE EXCLUSION CHROMATOGRAPHY;

ANTIBODIES, MONOCLONAL; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, GEL; DRUG STABILITY; DRUG STORAGE; HYDROGEN-ION CONCENTRATION; KINETICS; MODELS, CHEMICAL; PARTICLE SIZE; PROTEIN AGGREGATES; PROTEIN STABILITY; PROTEIN UNFOLDING; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE;

EID: 80052270546     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22633     Document Type: Article

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