RT Journal Article
T1 Degradation and in-use stability study of five marketed therapeutic monoclonal antibodies by generic weak cation exchange liquid chromatographic method ((WCX)HPLC/DAD).
A1 Martinez-Ortega, Antonio
A1 Herrera, Agustin
A1 Salmeron-Garcia, Antonio
A1 Cabeza, Jose
A1 Perez-Robles, Raquel
A1 Navas, Natalia
K1 (WCX)HPLC/DAD
K1 Charge variants analysis
K1 In-use mAbs stability
K1 Monoclonal antibodies
AB Therapeutic monoclonal antibodies (mAbs) represent a very important class of the current biopharmaceutics. The great complexity of their structure made necessary the use of different analytical approaches for assessing different physico-chemical properties. In this work, weak cation exchange (WCX) high performance liquid chromatography with diode array detection ((WCX)HPLC/DAD) is used to assess the charge variant profile. The method here developed combined the effect of ionic strength and controlled pH gradient and allows for the charge variants analysis of the five mAbs studied, namely bevacizumab (BVZ), cetuximab (CTX) infliximab (INF), rituximab (RTX) and trastuzumab (TTZ), which are among the most used mAbs worldwide. The differences in the charge variants in the natural isoforms of the mAbs promoted characteristic WCX chromatograms for each of mAbs that can be also useful for identification purposes. These chromatograms have provided to be suitable for tracking changes in the charge variants of each mAb analyzed both in controlled degraded and in stabilities study along time of in-use samples solutions at 2 mg/mL in 0.9% NaCl stored refrigerated (at 4 °C) and frozen (-20 °C) for two months. The results obtained indicated different stabilities of these mAbs, all IgG1, against degradation by different stressed environmental conditions and in-use stability along two months.
PB Elsevier BV
YR 2022
FD 2022-05-09
LK http://hdl.handle.net/10668/22293
UL http://hdl.handle.net/10668/22293
LA en
NO Martínez-Ortega A, Herrera A, Salmerón-García A, Cabeza J, Perez-Robles R, Navas N. Degradation and in-use stability study of five marketed therapeutic monoclonal antibodies by generic weak cation exchange liquid chromatographic method ((WCX)HPLC/DAD). J Chromatogr B Analyt Technol Biomed Life Sci. 2022 Jul 1;1203:123295.
NO Financial support was provided by the Projects FIS-PI10/00201 andFIS-PI17/00547(Instituto Carlos III, Ministerio de Economía y Competitividad, Spain); this project was also partially supported by European Regional Development Funds (ERDF). Raquel P´erez-Roblescurrently holds a postdoctoral position granted by the Junta de Andalucía, Spain. The authors would like to thank the Hospital PharmacyUnit of San Cecilio University Hospital for kindly supplying all themedicine samples.
DS RISalud
RD Apr 5, 2025