Impact of controlled ice nucleation on process performance and quality attributes of a lyophilized monoclonal antibody

International Journal of Pharmaceutics

Volumn 450, Issue 1-2, 2013, Pages 70-78

  Awotwe Otoo, David ^a   Agarabi, Cyrus ^a   Read, Erik K ^a   Lute, Scott ^a   Brorson, Kurt A ^a   Khan, Mansoor A ^a   Shah, Rakhi B ^a  

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

Author keywords

Controlled ice nucleation; Freezing; Lyophilization; Monoclonal antibody; Process performance

Indexed keywords

MONOCLONAL ANTIBODY;

ANIMAL CELL; ARTICLE; CONTROLLED STUDY; DRUG FORMULATION; FREEZE DRYING; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; NONHUMAN; PRIORITY JOURNAL;

ANTIBODIES, MONOCLONAL; CHEMISTRY, PHARMACEUTICAL; DRUG COMPOUNDING; FREEZE DRYING; IMMUNOGLOBULIN G; IMMUNOGLOBULIN KAPPA-CHAINS;

EID: 84877649664     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2013.04.041     Document Type: Article

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