Frozen state storage instability of a monoclonal antibody: Aggregation as a consequence of trehalose crystallization and protein unfolding

Pharmaceutical Research

Volumn 28, Issue 4, 2011, Pages 873-885

  Singh, Satish K ^a   Kolhe, Parag ^a   Mehta, Anjali P ^a   Chico, Steven C ^a   Lary, Alanta L ^a   Huang, Min ^a  

^a PFIZER INC   (United States)

Author keywords

aggregation; cryoprotectant; glass transition temperature; monoclonal antibody; trehalose

Indexed keywords

CRYOPROTECTIVE AGENT; IMMUNOGLOBULIN G ANTIBODY; IMMUNOGLOBULIN G2 ANTIBODY; MONOCLONAL ANTIBODY; SURFACTANT; TREHALOSE; UNCLASSIFIED DRUG;

ARTICLE; CONTROLLED STUDY; CRYOPRESERVATION; CRYOPROTECTION; CRYSTALLIZATION; GLASS TRANSITION TEMPERATURE; IMMUNOGLOBULIN AGGREGATE; LOW TEMPERATURE PROCEDURES; PRIORITY JOURNAL; PROTEIN FOLDING; PROTEIN STABILITY; REACTION TIME; STORAGE TEMPERATURE; TEMPERATURE SENSITIVITY;

ANTIBODIES, MONOCLONAL; CRYSTALLIZATION; DRUG STABILITY; DRUG STORAGE; FREEZING; IMMUNOGLOBULIN G; PROTEIN FOLDING; PROTEIN STABILITY; PROTEIN UNFOLDING; THERMODYNAMICS; TIME FACTORS; TREHALOSE; VISCOSITY;

EID: 79955599896     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-010-0343-z     Document Type: Article

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