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Assessing Photostability of mAb Formulations In Situ Using Light-Coupled NMR Spectroscopy.
Jack E Bramham1, Yujing Wang2, Stephanie A Moore2
1Department of Chemistry, School of Natural Sciences, Faculty of Science and Engineering, The University of Manchester, Manchester M1 7DN, U.K.
Analytical Chemistry
|June 7, 2024
Summary
Light exposure causes degradation in monoclonal antibodies (mAbs). This study reveals transient radicals form during UV-A illumination, persisting post-exposure, impacting mAb stability.
Area of Science:
- Biopharmaceutical stability
- Photodegradation mechanisms
- Spectroscopic analysis
Background:
- Monoclonal antibodies (mAbs) require stable formulations.
- UV light exposure induces chemical and physical degradation in mAbs.
- Understanding photodegradation intermediates and reactive species is limited.
Purpose of the Study:
- To investigate in situ spectral changes during and after UV-A illumination of mAb formulations.
- To identify transient reactive species and their impact on mAb stability.
- To elucidate the role of excipients in light-induced degradation.
Main Methods:
- Light-coupled Nuclear Magnetic Resonance (NMR) spectroscopy for in situ monitoring.
- UV-A illumination of sealed mAb formulations.
- Ex situ High-Performance Size-Exclusion Chromatography (HPSEC) for purity analysis.
Main Results:
- Transient radicals formed within minutes during UV-A illumination and persisted post-illumination.
- Both mAb and excipient signals were affected, showing irreversible degradation and partial recovery.
- Degradation was formulation-dependent, influenced by mAb type and excipients like polysorbate 80 (PS80) and methionine.
- HPSEC confirmed significant purity loss, indicating light-initiated degradation continuing in the dark.
Conclusions:
- UV-A light triggers complex degradation pathways in mAb formulations.
- Transient radicals play a role in both immediate and post-illumination degradation.
- Excipients influence the susceptibility of mAbs to light-induced degradation.
- Further research into photoreaction intermediates is crucial for mitigating biopharmaceutical degradation.
