{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Pritts JD"],"funding":["Center for Drug Evaluation and Research"],"pagination":["185-193"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12913286"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["43(1)"],"pubmed_abstract":["<h4>Background</h4>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.<h4>Methods</h4>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).<h4>Results</h4>Light stress increased high molecular weight species (HMWS), particularly in liquid formulations, as shown by size exclusion chromatography (Lyophili"],"journal":["Pharmaceutical research"],"pubmed_title":["Physicochemical Differences Observed in Photostability Studies of Lyophilized, Reconstituted, and Diluted Somatropin."],"pmcid":["PMC12913286"],"funding_grant_id":["FD999999"],"pubmed_authors":["Ortega-Rodriguez U","Rao VA","Pritts JD"],"additional_accession":[]},"is_claimable":false,"name":"Physicochemical Differences Observed in Photostability Studies of Lyophilized, Reconstituted, and Diluted Somatropin.","description":"<h4>Background</h4>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.<h4>Methods</h4>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).<h4>Results</h4>Light stress increased high molecular weight species (HMWS), particularly in liquid formulations, as shown by size exclusion chromatography (Lyophili","dates":{"release":"2026-01-01T00:00:00Z","publication":"2026 Jan","modification":"2026-07-16T06:57:12.538Z","creation":"2026-07-09T13:10:53.359Z"},"accession":"S-EPMC12913286","cross_references":{"pubmed":["41402682"],"doi":["10.1007/s11095-025-03986-1"]}}