Open AccessStability Evaluation of the Biosimilar Monoclonal Antibody Using Analytical Techniques
Author(s) -
Deniz Demirhan
Publication year - 2023
Publication title -
turkish journal of pharmaceutical sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.241
H-Index - 14
eISSN - 2148-6247
pISSN - 1304-530X
DOI - 10.4274/tjps.galenos.2022.47690
Subject(s) - chromatography , chemistry , sodium dodecyl sulfate , biosimilar , capillary electrophoresis , polyethylene glycol , isoelectric focusing , size exclusion chromatography , high performance liquid chromatography , medicine , organic chemistry , enzyme
Determination of the drug substance (DS) and drug product (DP) stability is especially important for biosimilar monoclonal antibodies since it can affect the quality, efficacy, and safety of the drugs. The main objective of this study was to determine the stability of the biosimilar candidate (TUR01) using state-of-the-art (current) analytical techniques.