RT Journal Article
T1 Comprehensive Analysis of Nivolumab, A Therapeutic Anti-Pd-1 Monoclonal Antibody: Impact of Handling and Stress.
A1 Torrente-Lopez, Anabel
A1 Hermosilla, Jesus
A1 Salmeron-Garcia, Antonio
A1 Cabeza, Jose
A1 Navas, Natalia
K1 UHPLC-MS
K1 comprehensive analytical characterisation
K1 forced degradation
K1 isoform profile
K1 nivolumab
AB Nivolumab, formulated in the medicine Opdivo® (10 mg/mL), is a therapeutic monoclonal antibody (mAb) used in the treatment of different types of cancer. Currently, there is insufficient knowledge about the behaviour of this protein with regards to the risk associated with its routine handling or unintentional mishandling, or when subjected to stress conditions in hospitals. These conditions can be simulated in forced degradation studies, which provide an in-depth understanding of the biophysical and biochemical properties of mAbs. In this study, we carried out a physicochemical and functional characterisation of nivolumab, which was subjected to various stress conditions: heat, freeze/thaw cycles, agitation, light exposure and high hypertonic solution. We used a wide range of analytical techniques: Far-UV CD, IT-FS, DLS, SE/UHPLC(UV)-[Native]MS, and ELISA. The results show that exposure to light was the stress test with the greatest impact on the samples, revelling the formation of non-natural dimers and a different isoform profile. In addition, nivolumab (Opdivo®) demonstrated stability up to 60 °C (1 h). As regards functionality all the nivolumab (Opdivo®) stressed samples were found to be stable except for those subjected to light and agitation, and to a lesser extent, those subjected to FTC 5 and NaCl stresses.
PB MDPI AG
SN 1999-4923
YR 2022
FD 2022-03-17
LK http://hdl.handle.net/10668/21547
UL http://hdl.handle.net/10668/21547
LA en
NO Torrente-López A, Hermosilla J, Salmerón-García A, Cabeza J, Navas N. Comprehensive Analysis of Nivolumab, A Therapeutic Anti-Pd-1 Monoclonal Antibody: Impact of Handling and Stress. Pharmaceutics. 2022 Mar 23;14(4):692
DS RISalud
RD Apr 8, 2025