Comparability assessments of process and product changes made during development of two different monoclonal antibodies

Biologicals

Volumn 39, Issue 1, 2011, Pages 9-22

  Lubiniecki, Anthony ^a   Volkin, David B ^a   Federici, Marcia ^a   Bond, Michael D ^a   Nedved, Michael L ^a   Hendricks, Linda ^a   Mehndiratta, Promod ^a   Bruner, Mark ^a   Burman, Sudhir ^a   DalMonte, Paul ^a   Kline, Jane ^a   Ni, Alex ^a   Panek, Mark E ^a   Pikounis, Bill ^a   Powers, Gordon ^a   Vafa, Omid ^a   Siegel, Rich ^a  

^a Pharmaceutical Development and Manufacturing Sciences   (United States)

Author keywords

Comparability; Formulation; IgG; Monoclonal antibodies; Stability

Indexed keywords

HUMAN IMMUNOGLOBULIN; LYSINE;

ANIMAL CELL; ANTIBODY STRUCTURE; ARTICLE; BIOEQUIVALENCE; BIOPROCESS; CARBOXY TERMINAL SEQUENCE; CELL CULTURE; CELL LINE; CHEMICAL STRUCTURE; CIRCULAR DICHROISM; COMPARATIVE STUDY; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DEGRADATION; DRUG FORMULATION; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG STABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; ISOELECTRIC FOCUSING; MASS SPECTROMETRY; MOUSE; NONHUMAN; PEPTIDE MAPPING; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; SIALYLATION;

ANIMALS; ANTIBODIES, MONOCLONAL; CELL LINE; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CIRCULAR DICHROISM; DRUG INDUSTRY; ELECTROPHORESIS, POLYACRYLAMIDE GEL; HUMANS; IMMUNOGLOBULIN G; K562 CELLS; PROTEIN BINDING; RECEPTORS, IGG; TECHNOLOGY, PHARMACEUTICAL;

EID: 79551563213     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2010.08.004     Document Type: Article

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