Date on Master's Thesis/Doctoral Dissertation


Document Type

Master's Thesis

Degree Name



Pharmacology and Toxicology

Degree Program

Pharmacology and Toxicology, MS

Committee Chair

Matoba, Nobuyuki

Committee Member

Ceresa, Brian

Committee Member

Palmer, Kenneth

Committee Member

Garbett, Nichola

Committee Member

Kirpich, Irina

Committee Member

Jala, Venkatakrishna

Author's Keywords

ulcerative colitis; mucosal healing; stability assessment; EPICERTIN


EPICERTIN is a biotherapeutic candidate for mucosal healing in ulcerative colitis (UC), a major type of inflammatory bowel disease (IBD). Despite the critical role of mucosal healing in achieving successful remission of UC, there are currently no targeted mucosal healing agents available. EPICERTIN has previously demonstrated epithelial repair and mucosal healing activity in colon epithelial cells, murine colitis models, and tissue explants from IBD patients, highlighting its therapeutic potential to meet this unmet need for UC patients. The development of appropriate chemistry, manufacturing, and controls (CMC) data will facilitate our ultimate goal to bring EPICERTIN to the clinic for a first-in-human (FIH) clinical study. To this end, this work describes the regulation-compliant long-term and forced degradation stability assessments of EPICERTIN DS to generate molecular stability and physicochemical property profiles.