Evaluation of a Cell-Based Potency Assay for Detection of the Potency of TrenibotulinumtoxinE^® (TrenibotE).

ABSTRACT: (1) Background: As an innovative drug derived from botulinum neurotoxin serotype E, TrenibotulinumtoxinE^® demonstrates a rapid onset and shorter effect. Due to concerns regarding specificity, test throughput, and animal welfare, a new cell-based potency assay (CBPA) method was developed for BoNT/E drug substance and drug product; independent evaluation of this new CBPA was required. (2) Methods: The CBPA for BoNT/E is a quantitative assay that measures the accumulated cleaved SNAP25₁₈₀ in human neuroblastoma cells. It involves sequential culturing, differentiation of cells, and then treatment with drug products. Data were analyzed using a quadratic parallel model via statistical software. Linearity was determined using five effective concentration levels. Key assay pa

SUBMITTER: Yang Y 

PROVIDER: S-EPMC12846514 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature