Biomay AG Receives FDA Approval for Manufacturing and Supply of Recombinant Cas9 Nuclease
Vienna, Austria – Biomay AG, a privately owned Contract Development and Manufacturing Organization (CDMO), announced today that it has successfully obtained approval from the U.S. Food and Drug Administration (FDA) for the manufacturing, testing, and release of recombinant Cas9 nuclease from its headquarters site in Vienna, Austria. This essential component of CRISPR-based gene editing therapies, including CASGEVY® (exagamglogene autotemcel) developed and launched by Vertex Pharmaceuticals, will now be available for use in the United States.
The FDA’s Center for Biologics Evaluation and Research (CBER) conducted an inspection of Biomay’s headquarters manufacturing site in Vienna’s Seestadt district in December 2024. No observations were made, and no Form FDA 483 was issued, allowing Biomay’s headquarters site to supply Cas9 for the United States.
Biomay operates two independent cGMP manufacturing sites, including its headquarters facility in Vienna Seestadt and a second site in Vienna’s downtown area. The FDA’s approval of Biomay’s headquarters site marks the company’s second successful FDA inspection, following the 2023 approval of Biomay’s downtown facility. The headquarters site is a state-of-the-art biomanufacturing facility that was recently constructed.
Founded in 1984, Biomay has been focused on the expression of recombinant proteins using E. coli. Today, the company offers cGMP services for the manufacturing of therapeutic proteins, plasmid DNA (pDNA), and messenger RNA (mRNA). Biomay’s CDMO services include process and analytical development, cell banking, cGMP manufacturing of drug substance, and aseptic filling of drug product.
“We are thrilled to have received FDA approval for the manufacturing and supply of recombinant Cas9 nuclease from our headquarters site,” said Dr. Angela Neubauer, SVP Client Business at Biomay AG. “This achievement is a testament to the high-quality standards and state-of-the-art facilities we have in place at Biomay. We look forward to continuing to provide top-notch services to our clients.”
For more information, please contact Dr. Angela Neubauer at request@biomay.com or visit Biomay AG’s website at www.biomay.com.
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