Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 604, Issue -, Pages -Publisher
ELSEVIER
DOI: 10.1016/j.ijpharm.2021.120723
Keywords
Photo-oxidation; Visible light; mAb; Light dosage; Stability; Photodegradation
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Funding
- Boehringer Ingelheim Pharma GmbH Co.
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This study investigated the photodegradation of three monoclonal antibodies under visible light. The results show that visible light can induce the formation of various oxidation-related species in the antibodies. The rate of degradation is dependent on light intensity, but the yield is correlated to the applied light dosage, following the Bunsen-Roscoe reciprocity law.
The present study investigated the photodegradation of three different monoclonal antibodies (mAb) by visible light. Several chromatographic techniques, such as size-exclusion and hydrophobic interaction chromatography as well as mass spectrometry were used to measure relative changes of various oxidation related monoclonal antibody species. The results show that visible light is indeed capable of inducing the formation of protein photo-oxidation products, such as acidic, basic, hydrophilic, and several other protein species with altered physicochemical properties. Although, the formation rate of degradants of these three protein species was dependent on the light source's intensity (I), their yield is clearly correlated to the applied light dosage (ld), which is defined as the product of light intensity I and irradiation time t (light dosage = I.t). Hence, our findings indicate that the degradation of monoclonal antibodies can be described according to the Bunsen-Roscoe reciprocity law. This correlation can be useful to assess the impact of photodegradation of biologics with regards to changes in light intensity and/or duration of light exposure of the protein, e.g. during the manufacturing of biologics.
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