Bio-Techne's Simple Western Technology Utilized In FDA Approval Of ZEVASKYN, Developed By Abeona Therapeutics

Bio-Techne Corporation (NASDAQ:TECH) today announced that its Simple Western™ Technology played a key role in supporting the FDA approval of ZEVASKYN™ (prademagene zamikeracel), the first autologous cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), developed by Abeona Therapeutics® (NASDAQ:ABEO). Throughout clinical development, Simple Western enabled precise identification and quantification of Collagen VII, a complex therapeutic target critical to ZEVASKYN's potency, supporting lot release testing for the viral vector and the cell therapy in a GMP setting.

Abeona selected Simple Western over competing methods like traditional western blot for its speed, reproducibility, picogram-level sensitivity, and minimal sample volume requirements. The platform effectively detected both the trimeric and monomeric forms of Collagen VII, addressing the analytical challenges posed by the protein's size and structure and supporting the regulatory requirements for potency and consistency.