The company announced its successful approval by the FDA for the manufacturing, testing and release of recombinant Cas9 nuclease from its headquarters site. Cas9 is an essential component of CRISPR-based gene editing therapies, including CASGEVY® (exagamglogene autotemcel) developed and launched by Vertex Pharmaceuticals.
Biomay's recent achievement refers to an inspection by the FDA's Center for Biologics Evaluation and Research (CBER) at Biomay's headquarters manufacturing site in Vienna, Seestadt in December 2024. No observation was found, and no Form FDA 483 was issued by the
authority, allowing Biomay's headquarters site to supply Cas9 for the United States.
Biomay operates two independent cGMP manufacturing sites, a headquarters facility in Vienna Seestadt, and a second site in Vienna downtown. The authority's approval of Biomay's headquarters site represents the company's second successful FDA inspection following the 2023 approval of Biomay's downtown facility. Biomay's headquarters site is a recently constructed, state-of-the-art biomanufacturing facility.