Biomay Obtains FDA Approval for Manufacturing of Cas9 Nuclease at Headquarters Site
The company 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. 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.
Biomay AG is a privately owned and fully integrated Contract Development and Manufacturing Organization (CDMO) based in Vienna, Austria. Founded in 1984, the expression of recombinant proteins by utilizing E. coli has been Biomay's business focus from the very beginning. Today, Biomay offers cGMP services for manufacturing of therapeutic proteins, plasmid DNA (pDNA) and messenger RNA (mRNA). The company's scope of CDMO services comprises process and analytical development, cell banking, cGMP manufacturing of drug substance and aseptic filling of drug product.
Contact:
Dr. Angela Neubauer, SVP Client Business; E-Mail: request@biomay.com / Biomay AG, Ada Lovelace-Str. 2, A-1220 Vienna, Austria www.biomay.com
Images

Subscribe to releases from news aktuell GmbH
Subscribe to all the latest releases from news aktuell GmbH by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from news aktuell GmbH
Holistic AI-Driven Cyber Security Platform: Schwarz Digits, XM Cyber and SentinelOne deepen Strategic Alliance18.9.2025 14:33:38 CEST | Press release
Strategic Partnership for a holistic, AI-Powered Security Platform: A product leveraging the capabilities of SentinelOne, XM Cyber, and Omniac creates a 360-degree security solution for companies and the public sector. Forging A Stronger Security Alliance: The integration of SentinelOnes’ SecOps solutions with XM Cyber's leading CTEM creates a powerful security platform. AI's Rapid Adoption Security Strategy: This partnership will mitigate the significant cybersecurity risks associated with AI adoption, to protect organizational assets. Sovereign Protection, already running for the first customer: The new solution is also available on Schwarz Digits' sovereign European cloud STACKIT. It is already in use at Schwarz Group companies.
Dr. Carl June and Dr. Michel Sadelain are being awarded the Broermann Medical Innovation Award 202518.9.2025 14:19:02 CEST | Press release
With prize money of one million euros, it is one of the most highly endowed medical awards in the world Awarded for groundbreaking pioneering work in cancer therapy using CAR-T cells Award Ceremony with Hessian Prime Minister Boris Rhein
PLAN-B NET ZERO honoured with the Future Award at Europe’s largest AI festival16.9.2025 10:25:47 CEST | Press release
Berlin – PLAN-B NET ZERO was honoured with the prestigious Future Award in front of 8,500 attendees at Europe’s largest AI festival, the Big Bang Festival. The award jury of the German Institute for Sustainability & Economics recognised the company’s visionary contribution to transforming the energy market and accelerating the energy transition through the integration of artificial intelligence, big data, and renewable energy. The independent jury was particularly impressed by PLAN-B NET ZERO’s ability to combine green energy with artificial intelligence, community-driven approaches, and innovative business models. The concept of transforming traditional electricity customers into active community members—who contribute to sustainable consumption through gamification, CO₂ tracking, and shared challenges—proved especially convincing. “This honour is a powerful signal and a validation of our mission to make energy not only CO2-free, but also smart, data-driven, and a shared experience,”
30 Years of BODY WORLDS15.9.2025 09:43:08 CEST | Press release
A Success Story That Has Changed the Way We See Ourselves
Europe's largest classic and modern classic car market makes history15.9.2025 09:38:00 CEST | Press release
(Ladenburg, Germany) – Veterama celebrates its 50th anniversary in Mannheim: From October 10 to 12, 2025, the Maimarkt grounds in Mannheim will be transformed into an Eldorado for lovers of classic mobility for the 50th time. What began in 1975 as a small exchange market with around 30 dealers, founded by Winfried A. Seidel and Walter Metz, is now a legendary market spectacle with over 4,000 exhibitors from all over Europe. The extensive grounds not only include a huge open space of 260,000 m², but also 15,000 m² of hall space where complete vehicles, spare parts, and accessories are presented. A special focus is on the large vehicle marketplace, where over 500 complete vehicles are on offer. The two- and four-wheelers from all eras and price ranges are sure to make every collector's heart beat faster. In response to customer requests, this year we are offering an early bird ticket, which is valid as a day ticket for Friday, a premium ticket from Friday to Sunday, and day tickets for S
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom