We previously showed that formulated therapeutic antibody drug substance (DS) are sensitive to ultra-violet (UV) light, as well as to visible light (380-700 nm). Exposure to indoor white light from daylight fluorescence lamps during manufacturing process can cause deterioration of product quality, including formation of high molecular weight aggregates, alteration of charge variant profiles, oxidization of tryptophan and methionine residues and darkening DS color/appearance. Here we present our new studies of potential impact factors on DS light sensitivity, such as color light used in DS manufacturing and storage area, DS protein concentration, metal chelating agents in formulation buffers and DS filling amount in disposable bioprocessing containers. These findings will help to assess and mitigate risks associated with light exposure during manufacturing.

Photo-degradation of therapeutic antibodies: Manufacturing aspects

ACS Fall 2021

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