Biomay AG, a leading Contract Development and Manufacturing Organization (CDMO) based in Vienna, Austria, has announced its successful approval by the U.S. Food and Drug Administration (FDA) for the manufacturing, testing, and release of recombinant Cas9 nuclease from its headquarters site. This achievement marks a significant milestone for the company and its role in the development of CRISPR-based gene editing therapies.
Cas9 nuclease is a crucial component of CRISPR-based therapies, including CASGEVY® (exagamglogene autotemcel), which was developed and launched by Vertex Pharmaceuticals. With the FDA’s approval, Biomay’s headquarters site, located in Vienna Seestadt, is now authorized to supply Cas9 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 December 2024. The site was found to have no observations, and no Form FDA 483 was issued, demonstrating Biomay’s compliance with FDA regulations and standards.
Biomay operates two independent cGMP manufacturing sites, including the headquarters facility in Vienna Seestadt and a second site in Vienna downtown. The FDA’s approval of Biomay’s headquarters site marks the company’s second successful inspection following the 2023 approval of its downtown facility. The headquarters site is a state-of-the-art biomanufacturing facility that was recently constructed.
Founded in 1984, Biomay AG has been focused on the expression of recombinant proteins using E. coli from the very beginning. 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.
Dr. Angela Neubauer, SVP Client Business at Biomay, can be contacted for further information at request@biomay.com. Biomay AG’s headquarters are located at Ada Lovelace-Str. 2, A-1220 Vienna, Austria. For more information about the company and its services, please visit www.biomay.com.
Derick is an experienced reporter having held multiple senior roles for large publishers across Europe. Specialist subjects include small business and financial emerging markets.