Bio-Techne technology used in FDA-approved gene therapy ZEVASKYN

Bio-Techne Corporation (NASDAQ: TECH) announced that its Simple Western technology supported the FDA approval of ZEVASKYN (prademagene zamikeracel), the first autologous cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB). The therapy was developed by Abeona Therapeutics (NASDAQ: ABEO).

The Simple Western platform enabled identification and quantification of Collagen VII, a therapeutic target in ZEVASKYN's potency testing. Abeona selected the technology for its speed, reproducibility, picogram-level sensitivity, and minimal sample volume requirements during clinical development and lot release testing.

RDEB is a genetic skin disorder caused by mutations in the COL7A1 gene, leading to misfolding of Collagen VII protein. Patients experience severe blistering, chronic wounds, scarring, and increased risk of squamous cell carcinoma. Previous treatment focused on symptomatic management.

The platform provided GMP-compliant data to ensure consistency of each autologous ZEVASKYN product lot. The technology detected both trimeric and monomeric forms of Collagen VII, addressing analytical challenges posed by the protein's size and structure.

"ZEVASKYN represents a significant milestone for patients with RDEB and for the field of cell-based gene therapy," said Will Geist, Bio-Techne's President, Protein Sciences Segment.

Dr. Ann Durbin, Senior Director of Quality Control at Abeona Therapeutics, said the Simple Western platform was selected for quality control laboratories due to its reproducibility, time-to-result, and GMP compliance. The validated assay quantifies Collagen VII to support release testing of autologous ZEVASKYN lots and viral vector release and stability testing.

Bio-Techne generated approximately $1.2 billion in net sales in fiscal 2024 and employs approximately 3,100 people worldwide. The information was disclosed in a company press release.

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