Understanding the freezing of biopharmaceuticals: First-principle modeling of the process and evaluation of its effect on product quality

Journal of Pharmaceutical Sciences

Volumn 102, Issue 8, 2013, Pages 2495-2507

  Radmanovic, Nikola ^a   Serno, Tim ^a   Joerg, Susanne ^a   Germershaus, Oliver ^b  

^a NOVARTIS PHARMA AG   (Switzerland)

^b UNIVERSITY OF WÜRZBURG   (Germany)

Author keywords

Mathematical model; Processing; Protein aggregation; Protein formulation; Stability; Temperature

Indexed keywords

CRYOPROTECTIVE AGENT; MONOCLONAL ANTIBODY; NONIONIC SURFACTANT;

ARTICLE; COOLING; DRUG QUALITY; FREEZE THAWING; FREEZING; GEL PERMEATION CHROMATOGRAPHY; HEAT TRANSFER; LIGHT SCATTERING; MATHEMATICAL MODEL; PHARMACEUTICS; TEMPERATURE; THERMAL CONDUCTIVITY; TURBIDITY;

EID: 84881022649     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23642     Document Type: Article

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