Dear Community,
Excited to share this AAPS webinar on a highly relevant topic featuring speaker Sreedhara Alavattam, Genentech. Please register while space is available ! Dec 7th, 12:30 PM EST
https://www.pathlms.com/aaps/webinars/38836
Photostability of Biologics
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
Thanks
Sterile Products Community and Stability community collaboration
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Vinaya Kapoor, PhD
Vice President, Regulatory Affairs
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