Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept

mAbs

Volumn 8, Issue 6, 2016, Pages 1136-1155

  Cho, Ick Hyun ^a   Lee, Nayoung ^a   Song, Dami ^a   Jung, Seong Young ^a   Bou Assaf, George ^b   Sosic, Zoran ^b   Zhang, Wei ^b   Lyubarskaya, Yelena ^b  

^a Samsung Bioepis Co Ltd   (South Korea)

^b BIOGEN   (United States)

Author keywords

Benepali; biosimilar; Brenzys; critical quality attribute; etanercept; Fc fusion protein; SB4

Indexed keywords

BIOSIMILAR AGENT; DISULFIDE; ETANERCEPT; GALACTOSE; LYMPHOTOXIN; N GLYCOLOYLNEURAMINIC ACID; SB4; SIALIC ACID; TUMOR NECROSIS FACTOR RECEPTOR; UNCLASSIFIED DRUG; N ACETYLNEURAMINIC ACID; N-GLYCOLYLNEURAMINIC ACID; NEURAMINIC ACID DERIVATIVE; NONSTEROID ANTIINFLAMMATORY AGENT;

AMINO ACID SEQUENCE; APOPTOSIS ASSAY; BIOLOGICAL ACTIVITY; CIRCULAR DICHROISM; CONTROLLED STUDY; DEUTERIUM HYDROGEN EXCHANGE; DIFFERENTIAL SCANNING CALORIMETRY; DRUG EFFICACY; DRUG IMPURITY; DRUG PURITY; DRUG QUALITY; DRUG SAFETY; DRUG STRUCTURE; EVALUATION STUDY; GLYCOSYLATION; HUMAN; HYDROPHOBIC INTERACTION CHROMATOGRAPHY; HYDROPHOBICITY; IMMUNOGENICITY; INFRARED SPECTROSCOPY; LIMIT OF QUANTITATION; MOLECULAR SIZE; MOLECULAR WEIGHT; PEPTIDE MAPPING; PHYSICAL CHEMISTRY; PROTEIN PROCESSING; QUALITY CONTROL; SIZE EXCLUSION CHROMATOGRAPHY; SURFACE PLASMON RESONANCE; ANIMAL; CHEMISTRY; CHO CELL LINE; CRICETULUS; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; IMMUNOLOGY; PH; PROTEIN CONFORMATION; SEQUENCE ANALYSIS; UNITED STATES;

ANIMALS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; BIOSIMILAR PHARMACEUTICALS; CALORIMETRY, DIFFERENTIAL SCANNING; CHO CELLS; CHROMATOGRAPHY, GEL; CRICETULUS; ETANERCEPT; EUROPEAN UNION; GLYCOSYLATION; HUMANS; HYDROGEN-ION CONCENTRATION; N-ACETYLNEURAMINIC ACID; NEURAMINIC ACIDS; PEPTIDE MAPPING; PROTEIN CONFORMATION; PROTEIN PROCESSING, POST-TRANSLATIONAL; SEQUENCE ANALYSIS, PROTEIN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84976532675     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.1080/19420862.2016.1193659     Document Type: Article

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