Date on Master's Thesis/Doctoral Dissertation
5-2024
Document Type
Master's Thesis
Degree Name
M.S.
Department
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
Abstract
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.
Recommended Citation
Kittle, Wendy Michelle, "Preclinical stability assessment of EPICERTIN, a biotherapeutic candidate for ulcerative colitis mucosal healing." (2024). Electronic Theses and Dissertations. Paper 4345.
Retrieved from https://ir.library.louisville.edu/etd/4345
