Improved Comparative Signature Diagrams to Evaluate Similarity of Storage Stability Profiles of Different IgG1 mAbs

Journal of Pharmaceutical Sciences

Volumn 105, Issue 3, 2016, Pages 1028-1035

  Kim, Jae Hyun ^a   Joshi, Sangeeta B ^a   Esfandiary, Reza ^b   Iyer, Vidyashankara ^b   Bishop, Steven M ^b   Volkin, David B ^a   Middaugh, Charles Russell ^a  

^a UNIVERSITY OF KANSAS   (United States)

^b MEDIMMUNE   (United States)

Author keywords

aggregation; biosimilarity; capillary isoelectric focusing; comparability; Comparative Signature Diagram; deamidation; IgG1; mAbs; SEC

Indexed keywords

DIMER; IMMUNOGLOBULIN G1 ANTIBODY; MONOMER; BIOSIMILAR AGENT; IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY;

ANALYTIC METHOD; ARTICLE; COMPARATIVE SIGNATURE DIAGRAM; CONTROLLED STUDY; DRUG STABILITY; DRUG STORAGE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH TEMPERATURE; QUANTITATIVE ANALYSIS; SIZE EXCLUSION CHROMATOGRAPHY; CHEMISTRY; MEDICINAL CHEMISTRY; PROCEDURES; PROTEIN STABILITY;

ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, GEL; DRUG STABILITY; DRUG STORAGE; IMMUNOGLOBULIN G; PROTEIN STABILITY;

EID: 84964510394     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1016/j.xphs.2016.01.008     Document Type: Article

References (5)

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