Physicochemical Differences Observed in Photostability Studies of Lyophilized, Reconstituted, and Diluted Somatropin.

ABSTRACT:

Background

While photostability testing conditions for biologics are often based on small molecule standards, the unique characteristics of proteins necessitate a deeper understanding of appropriate testing and controls. This study examines the effects of light stress on various presentations of somatropin, a therapeutic growth hormone.

Methods

Somatropin was exposed to light in lyophilized, reconstituted, and diluted forms. Quality attribute changes were analyzed using size exclusion chromatography, micro-fluidic imaging, imaged capillary isoelectric focusing, and liquid chromatography mass spectrometry (LC-MS).

Results

Light stress increased high molecular weight species (HMWS), particularly in liquid formulations, as shown by size exclusion chromatography (Lyophili

SUBMITTER: Pritts JD 

PROVIDER: S-EPMC12913286 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature