Ester hydrolysis of polysorbate 80 in mAb drug product: Evidence in support of the hypothesized risk after the observation of visible particulate in mAb formulations

Journal of Pharmaceutical Sciences

Volumn 103, Issue 8, 2014, Pages 2268-2277

  Labrenz, Steven R ^a  

^a Janssen RandD LLC   (United States)

Author keywords

biopharmaceuticals characterization; chromatography; hydrolysis; protein aggregation; protein formulation; stability; surfactants

Indexed keywords

ESTER; FATTY ACID; FERROUS ION; IMMUNOGLOBULIN G; MACROGOL; MONOCLONAL ANTIBODY; OLEIC ACID; POLYSORBATE 80; SORBITAN; SURFACTANT; TERT BUTYL HYDROPEROXIDE; WATER; POLYSORBATE; PROTEIN AGGREGATE;

ARTICLE; CHEMICAL REACTION; CHROMATOGRAPHY; COLLOID; DRUG FORMULATION; DRUG STABILITY; ENZYME ACTIVITY; ENZYME IMMOBILIZATION; FLOW RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYDROLYSIS; OXIDATION; PARTICLE SIZE; PARTICULATE MATTER; PROTEIN AGGREGATION; QUALITY CONTROL PROCEDURES; CHEMISTRY; OXIDATION REDUCTION REACTION; PROTEIN STABILITY;

ANTIBODIES, MONOCLONAL; ESTERS; HYDROLYSIS; IMMUNOGLOBULIN G; OXIDATION-REDUCTION; POLYSORBATES; PROTEIN AGGREGATES; PROTEIN STABILITY; SURFACE-ACTIVE AGENTS;

EID: 84905120807     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24054     Document Type: Article

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