- Bio-Techne's Simple Western™ Technology crucial in FDA's approval of ZEVASKYN™, a pioneering cell-based gene therapy.
- Chosen for superior capabilities over traditional methods, offering picogram-level sensitivity and minimal sample needs.
- The platform supports GMP-compliant lot release testing, addressing complex analytical challenges in biotech development.
Bio-Techne Corporation (TECH, Financial) has announced that its Simple Western™ Technology was instrumental in achieving FDA approval for ZEVASKYN™ (prademagene zamikeracel), the first autologous cell-based gene therapy aimed at treating recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic skin disorder. Developed in collaboration with Abeona Therapeutics (ABEO), ZEVASKYN™ represents a significant advancement in gene therapy.
The Simple Western platform was selected due to its advanced capabilities, including speed, reproducibility, and the ability to detect picogram-level quantities of Collagen VII, a crucial protein for ZEVASKYN’s potency testing. These attributes allowed precise analysis of Collagen VII’s trimeric and monomeric forms, critical for regulatory consistency and potency assessments.
RDEB is caused by mutations in the COL7A1 gene, leading to misfolding of Collagen VII, essential for maintaining skin integrity. Traditionally focused on symptomatic management, treatment options for RDEB were limited until ZEVASKYN™. The platform's high-throughput capabilities and GMP compliance made it possible to generate consistent, standardized data crucial for product lot testing.
The collaboration between Bio-Techne and Abeona Therapeutics highlights Bio-Techne's technical leadership in the cell and gene therapy space, providing the necessary tools to meet stringent regulatory standards. This approval not only underscores the commercial value of Simple Western but also positions Bio-Techne as a contender in the high-growth sector of gene therapy development.
