Abstract
UV and ambient light-induced modifications and related degradation of therapeutic proteins are observed during manufacturing and storage. Therefore, to ensure product quality, protein formulations need to be analyzed with respect to photo-degradation processes and eventually protected from light exposure. This task usually demands the application and combination of various analytical methods. This review addresses analytical aspects of investigating photo-oxidation products and related mediators such as reactive oxygen species generated via UV and ambient light with well-established and novel techniques.
Highlights
Therapeutic proteins such as monoclonal antibodies are important alternatives to small chemical drugs
This review addresses analytical aspects of investigating photo-oxidation products and related mediators such as reactive oxygen species generated via UV and ambient light with well-established and novel techniques
The aim of the present review is to provide an updated and broad overview of analyticTalhteecahinmiquoefsthfoer pinrveessetnigtartienvgiepwhoitso-tiondpurcoevdidaletearnatiuonpsdoaftetdhearanpdeubtricoapdrootevinerfvoire-w of amnaullyattiicoanl ctoecmhpnoiqnuenetssfworitihntvheesmtigaaintinfogcupshoontoR-iOnSdufocremdaatliotenravtiiaopnhsootfo-tchheermapiceaultriceapcrtoiotneisn formanudlarteiosnulctionmg pporonteenintsmwoidthifitchaetiomnasi.n focus on ROS formation via photo-chemical reactions and resulting protein modifications
Summary
Therapeutic proteins such as monoclonal antibodies (mAbs) are important alternatives to small chemical drugs. It is described in the literature that the exposure of therapeutic proteins to light encountered during, e.g., common manufacturing processes such as purification, fill and finish, storage or administration in the clinic, may promote the formation of various protein modifications [6,7,8,9], which might show immunological effects [10]. These aberrant byproducts can be generated via two photo-oxidation processes that proceed either via a so-called type I or type II oxidation pathway [11]. The aim of the present review is to provide an updated and broad overview of analyticTalhteecahinmiquoefsthfoer pinrveessetnigtartienvgiepwhoitso-tiondpurcoevdidaletearnatiuonpsdoaftetdhearanpdeubtricoapdrootevinerfvoire-w of amnaullyattiicoanl ctoecmhpnoiqnuenetssfworitihntvheesmtigaaintinfogcupshoontoR-iOnSdufocremdaatliotenravtiiaopnhsootfo-tchheermapiceaultriceapcrtoiotneisn formanudlarteiosnulctionmg pporonteenintsmwoidthifitchaetiomnasi.n focus on ROS formation via photo-chemical reactions and resulting protein modifications
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