An integrated process analytical technology (PAT) approach to monitoring the effect of supercooling on lyophilization product and process parameters of model monoclonal antibody formulations

Journal of Pharmaceutical Sciences

Volumn 103, Issue 7, 2014, Pages 2042-2052

  Awotwe Otoo, David ^a   Agarabi, Cyrus ^a   Khan, Mansoor A ^a  

^a Division of Product Quality Research Office of Testing and Research United States Food and Drug Administration   (Colombia)

Author keywords

dry layer thickness; formulation; freeze drying; ice nucleation; lyophilization; monoclonal antibody; primary drying; process analytical technology (PAT); product temperature; secondary drying

Indexed keywords

MONOCLONAL ANTIBODY; IMMUNOGLOBULIN G;

ABSORPTION SPECTROSCOPY; ARTICLE; COOLING; DRUG FORMULATION; FLOW RATE; FREEZE DRYING; MOISTURE; NON INVASIVE MEASUREMENT; PROCESS ANALYTICAL TECHNOLOGY; PROCESS MONITORING; PROCESS TECHNOLOGY; SURFACE PROPERTY; TUNABLE DIODE LASER ABSORPTION SPECTROSCOPY; WATER VAPOR; CHEMICAL MODEL; CHEMISTRY; CRYSTALLIZATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG STABILITY; MEDICINAL CHEMISTRY; PHARMACEUTICS; PROCEDURES; TRANSITION TEMPERATURE;

ANTIBODIES, MONOCLONAL; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; DRUG COMPOUNDING; DRUG STABILITY; FREEZE DRYING; IMMUNOGLOBULIN G; MODELS, CHEMICAL; SURFACE PROPERTIES; TECHNOLOGY, PHARMACEUTICAL; TRANSITION TEMPERATURE;

EID: 84903148869     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24005     Document Type: Article

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