Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab

Background ABP 501 is being developed as a biosimilar to adalimumab. Comprehensive comparative analytical characterization studies have been conducted and completed. Objective The objective of this study was to assess analytical similarity between ABP 501 and two adalimumab reference products (RPs),...

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Veröffentlicht in:	BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy biopharmaceuticals, and gene therapy, 2016-08, Vol.30 (4), p.321-338
Hauptverfasser:	Liu, Jennifer, Eris, Tamer, Li, Cynthia, Cao, Shawn, Kuhns, Scott
Format:	Artikel
Sprache:	eng
Schlagworte:	Adalimumab - chemistry Adalimumab - pharmacology Animals Antibodies Arthritis Biological products Biomedical and Life Sciences Biomedicine Biosimilar Pharmaceuticals - analysis Biosimilar Pharmaceuticals - chemistry Biosimilar Pharmaceuticals - pharmacology Calorimetry, Differential Scanning Cancer Research CHO Cells - drug effects Chromatography Chromatography, High Pressure Liquid - methods Circular Dichroism Cricetulus Drug Stability Dynamic Light Scattering Electrophoresis, Capillary - methods Information services Isoelectric Point Manufacturing Molecular Medicine Original Original Research Article Peptide Mapping Peptides Pharmaceutical industry Pharmacotherapy Product development Quality Spectroscopy, Fourier Transform Infrared Technical communication Tumor necrosis factor-TNF Ultracentrifugation
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