Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product

Purpose ABP 710 has been developed as a biosimilar to infliximab reference product (RP). The objective of this study was to assess analytical similarity (structural and functional) between ABP 710 and infliximab RP licensed by the United States Food and Drug Administration (infliximab [US]) and the...

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Veröffentlicht in:	Pharmaceutical research 2020-06, Vol.37 (6), p.114-114, Article 114
Hauptverfasser:	Saleem, Ramsey, Cantin, Greg, Wikström, Mats, Bolton, Glen, Kuhns, Scott, McBride, Helen J., Liu, Jennifer
Format:	Artikel
Sprache:	eng
Schlagworte:	Amino Acid Sequence Amino acids Antibodies, Monoclonal - analysis Biochemistry Biological products Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Biosimilar Pharmaceuticals - analysis Biosimilar Pharmaceuticals - chemistry Circular Dichroism Humans Immunotherapy Impurities Infliximab Infliximab - analysis Infliximab - chemistry Medical Law Monoclonal antibodies Nutrient content Pharmacology/Toxicology Pharmacy Polysaccharides Post-translation Protein Processing, Post-Translational Quality management Research Paper Spectroscopy, Fourier Transform Infrared Structure-function relationships TNF inhibitors Tumor necrosis factor-α
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