Authors
Eva-Maria Baur, Lukas Bollenbach, Torsten Schultz-Fademrecht, Dariush Hinderberger, Michaela Blech, Patrick Garidel
Published in
Pharmaceutical development and technology. Pages 1-25. Aug 29, 2026. Epub Aug 29, 2026.
Abstract
This study focuses on the comparative characterisation of two specific light sources and their influence on the photooxidation of monoclonal antibodies (mAbs) within the context of biopharmaceutical development. Three different mAbs were exposed to visible light (400-800 nm) using fluorescent and LED (light-emitting diode) lamps, with particular attention paid to their different light spectra. To eliminate potential influence of the presence of specific excipients on photooxidation processes, all samples were formulated in pure water.Photodegradation was assessed by means of the following techniques: Size exclusion chromatography (SEC) was used to quantify the degradation profile of the protein, where the monomer content, high (HMW) and low (LMW) molecular weight species were examined. The impact of Fc-oxidation was achieved through Protein A chromatography, while ion exchange chromatography (IEC) was employed to monitor the formation of charge variants. Mass spectrometry was utilised to identify site-specific oxidation of methionine and tryptophan residues.Spectral analysis revealed that the LED spectrum is characterised by a significant emission at 451 nm, followed by a broad peak between 480 nm and 800 nm. In contrast, the fluorescent lamp exhibited distinct main sharp peaks located at 436 nm, 545 nm and 612 nm.The results of the degradation analysis demonstrate that photooxidation occurs in a light dosage-dependent manner, with the extent of this process being contingent upon the antibody itself. For example, depending on the mAb tested, in the monomer content is reduced between -1% to -4%. For the Fc-oxidised variants, changes were observed from +5% to +20%. For the IEC main peak decrease, changes from -2% to -8% were detected. The study revealed that the degree of degradation was comparable, albeit to a slightly less extent, under the influence of tested LED lighting in comparison to the specified fluorescent exposure. The main degradation effects were observed in Fc oxidation levels, HMW changes and acidic and basic peak group content.The reduced effects of protein degradation observed under the influence of the used LED lighting are likely due to the reduced presence of shorter wavelength contributions, which are more effective in promoting electron excitation and subsequent oxidative reactions. These findings emphasise the importance of conducting comparative analyses of photodegradation studies. To enable a comprehensive evaluation of the impact of lighting systems on photodegradation in a pharmaceutical setting, it is imperative that they are meticulously characterised.
PMID:
42667144
Bibliographic data and abstract were imported from PubMed on 29 Aug 2026.
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