{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:01:41Z","timestamp":1787029301107,"version":"build-2736575974"},"reference-count":30,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2025,2,15]],"date-time":"2025-02-15T00:00:00Z","timestamp":1739577600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007028","name":"Leona M. and Harry B. Helmsley Charitable Trust","doi-asserted-by":"publisher","award":["2014PG-MED001"],"award-info":[{"award-number":["2014PG-MED001"]}],"id":[{"id":"10.13039\/100007028","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007028","name":"Leona M. and Harry B. Helmsley Charitable Trust","doi-asserted-by":"publisher","award":["R01 DK123712"],"award-info":[{"award-number":["R01 DK123712"]}],"id":[{"id":"10.13039\/100007028","id-type":"DOI","asserted-by":"publisher"}]},{"name":"U.S. National Institutes of Health grant","award":["2014PG-MED001"],"award-info":[{"award-number":["2014PG-MED001"]}]},{"name":"U.S. National Institutes of Health grant","award":["R01 DK123712"],"award-info":[{"award-number":["R01 DK123712"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Background\/Objectives: EPICERTIN, a biotherapeutic candidate for mucosal healing in inflammatory bowel disease (IBD) and other mucosal disorders, was subjected to an extensive long-term stability program to evaluate its molecular stability and physicochemical properties. Additionally, a forced degradation assessment was conducted to identify EPICERTIN\u2019s degradation products under various conditions, including thermal stress, pH variations, agitation, and oxidation. Methods: The stability of EPICERTIN drug substance (DS), formulated in phosphate-buffered saline (PBS) at 1 mg\/mL and stored at 5 \u00b0C and 25 \u00b0C\/60% relative humidity (RH), was monitored over a 2-year period, referencing relevant regulatory guidelines. Evaluations of EPICERTIN DS over the 24-month period included assessment of purity by SDS-PAGE and size exclusion high performance liquid chromatography (SEC-HPLC), identity by electrospray ionization mass spectrometry (ESI-MS) intact mass analysis and Western blotting, and potency by GM1-binding KDEL-detection ELISA (GM1\/KDEL ELISA). The forced degradation patterns were analyzed by assessing purity (using SEC-HPLC and SDS-PAGE), potency (via GM1\/KDEL ELISA), and intact mass (via ESI-MS). Results: The results overall support that EPICERTIN DS remains stable for 2 years under the tested conditions. The forced degradation assessment effectively identified degradation products, particularly under conditions of high temperatures (above 40 \u00b0C for 24 h), low pH values (pH 1 and 4), and oxidation upon exposure to 2% H2O2. Conclusions: These findings highlight EPICERTIN\u2019s robust long-term stability in PBS formulation, reinforcing its potential as a viable drug candidate for the treatment of IBD.<\/jats:p>","DOI":"10.3390\/pharmaceutics17020259","type":"journal-article","created":{"date-parts":[[2025,2,17]],"date-time":"2025-02-17T04:40:25Z","timestamp":1739767225000},"page":"259","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Preclinical Long-Term Stability and Forced Degradation Assessment of EPICERTIN, a Mucosal Healing Biotherapeutic for Inflammatory Bowel Disease"],"prefix":"10.3390","volume":"17","author":[{"given":"Wendy M.","family":"Kittle","sequence":"first","affiliation":[{"name":"Department of Pharmacology and Toxicology, School of Medicine, University of Louisville, Louisville, KY 40202, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Micaela A.","family":"Reeves","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Toxicology, School of Medicine, University of Louisville, Louisville, KY 40202, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley E.","family":"Fulkerson","sequence":"additional","affiliation":[{"name":"Brown Cancer Center, School of Medicine, University of Louisville, Louisville, KY 40202, USA"},{"name":"Center for Predictive Medicine, School of Medicine, University of Louisville, Louisville, KY 40202, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krystal T.","family":"Hamorsky","sequence":"additional","affiliation":[{"name":"Brown Cancer Center, School of Medicine, University of Louisville, Louisville, KY 40202, USA"},{"name":"Center for Predictive Medicine, School of Medicine, University of Louisville, Louisville, KY 40202, USA"},{"name":"Department of Medicine, School of Medicine, University of Louisville, Louisville, KY 40202, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Morris","sequence":"additional","affiliation":[{"name":"Center for Predictive Medicine, School of Medicine, University of Louisville, Louisville, KY 40202, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen T.","family":"Kitterman","sequence":"additional","affiliation":[{"name":"Center for Predictive Medicine, School of Medicine, University of Louisville, Louisville, KY 40202, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael L.","family":"Merchant","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Toxicology, School of Medicine, University of Louisville, Louisville, KY 40202, USA"},{"name":"Department of Medicine, School of Medicine, University of Louisville, Louisville, KY 40202, USA"},{"name":"Core and Clinical Proteomics Laboratories, University of Louisville, Louisville, KY 40202, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7231-3004","authenticated-orcid":false,"given":"Nobuyuki","family":"Matoba","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Toxicology, School of Medicine, University of Louisville, Louisville, KY 40202, USA"},{"name":"Brown Cancer Center, School of Medicine, University of Louisville, Louisville, KY 40202, USA"},{"name":"Center for Predictive Medicine, School of Medicine, University of Louisville, Louisville, KY 40202, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,2,15]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"91","DOI":"10.3748\/wjg.v20.i1.91","article-title":"Inflammatory bowel disease: Pathogenesis","volume":"20","author":"Zhang","year":"2014","journal-title":"World J. 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