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MAbs are exposed to light during drug product manufacturing, impacting product quality. Based on data published in recent literature, it is evident that mAbs are significantly photosensitive.
In this presentation, Sreedhara Alavattam of Genentech discusses how light conditions affect protein stability and how the biophysical properties of molecules influence photosensitivity. In addition, learn about the factors to consider when conducting a light room temperature study.
Register at: Photostability of Biologics | AAPS
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Additional Details:
Monoclonal antibodies (mAbs) are exposed to light during drug product (DP) manufacturing and the acceptable levels of light exposure needs to be determined based on the impact on product quality. Based on data published in recent literature it is evident that mAbs are very photosensitive. Surface active tryptophans have been implicated in several photochemical mechanisms, including in "antibody catalyzed water oxidation pathways". These mechanisms and underlying photochemical concepts will be discussed as they pertain to mAb stability.
ICH Q1B conditions were developed based on small molecule pharmaceuticals and have been shown to be quite harsh for mAbs. It is our recommendation to conduct an appropriate ambient light study, relevant to manufacturing conditions, on individual protein products during development to determine its photostability. A comprehensive assessment of fill/finish facilities should be performed, including quantifying UV and visible light.
Learning Objectives:
- How light conditions affect protein stability
- Factors to consider designing room temperature/room light studies representative of manufacturing conditions for your molecule
- How biophysical properties of molecule influences light sensitivity
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About the Speaker
Sreedhara is currently a Technical Development Distinguished Scientist at Genentech, Inc. He has over 20 years of experience in the biotechnology industry working with biologics (peptides, proteins and nucleic acids) and small molecule formulations. He has worked on several approved products, including initiating and leading the development for the first co-formulated product (Herceptin plus Pertuzumab, Phesgo®), CMC efforts of an approved antibody drug conjugate and several mAbs. His research interests are in chemical degradation (oxidative and photooxidative mechanisms, free radical mediated degradation of proteins) and various aggregation mechanisms for mAbs. Sreedhara currently leads several programs in early development including drug delivery efforts within the global strategy teams at Roche-Genentech. Prior to joining Genentech he has worked at Battelle Memorial Institute and Johnson & Johnson wherein he worked on protein stabilization as well as small molecule formulation development for controlled release applications and pulmonary delivery. He has over 50 publications, 4 book chapters, several patents and patent applications and an invited speaker at various national and international conferences. Currently he is also an adjunct associate professor at University of Kansas and a scientific advisor for J. Pharm. Sci. He also serves as a reviewer for Molecular Pharmaceutics, Pharmaceutical Research, J. Pharm. Sci, Biotech. Progress and mAbs. In addition to his interest in science, Sreedhara is an avid wildlife photographer
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