Latest news with #Biomay
Associated Press
09-05-2025
- Business
- Associated Press
Biomay Launches FDA-Grade CRISPR/Cas9 Nuclease for Off-the-Shelf Purchase
Biomay, a leading manufacturer of recombinant proteins, today announced the commercial availability of its CRISPR/Cas9 nuclease, marking a significant addition to its off-the-shelf product portfolio for genome-editing applications. Clients purchasing Biomay´s Cas9 will benefit from the company´s unparalleled track record and expertise as a market-registered GMP-manufacturer of the nuclease. Biomay is the FDA-approved manufacturer of recombinant Cas9 as the essential component of CASGEVY®, the very first CRISPR genome editing product on the market. Biomay's Cas9 (internal code 'BMC9') is based on the classical wild-type Cas9 nuclease fromStreptococcus pyogenes. The Cas9 manufacturing process has beende novodeveloped, GMP-implemented and PPQ-validated by Biomay. GMP and RUO manufacturing is performed by fermentation withE. coliand by purification with chromatographic methods. By quality control with a comprehensive set of validated analytical assays, the consistent integrity, purity and potency of the product is secured. 'The addition of Cas9 to Biomay's off-the-shelf portfolio aligns with our mission to provide high-quality and scalable solutions for emerging therapeutic modalities,'said Dr. Hans Huber, CEO of Biomay.'With this launch, we are expanding access to a critical component of gene-editing workflows, backed by our proven manufacturing expertise. Biomay´s off-the-shelf distributed Cas9, in combination with our made-to-order GMP services, will guarantee full scalability and GMP compliance throughout the whole product lifecycle. Biomay´s latest addition further strengthens the company's position as a key supplier in the field of gene and cell therapies. The CRISPR/Cas system, a transformative gene-editing technology, whose discovery was honored with the 2020 Nobel Prize in Chemistry, enables precise and efficient modification of genomic sequences. About Biomay: Biomay AG is a fully integrated Contract Development and Manufacturing Organization (CDMO) based in Vienna, Austria. Founded in 1984, the expression of recombinant proteins inE. colihas been Biomay's business focus yet from its beginning. Today, Biomay offers cGMP services for manufacturing of messenger RNA (mRNA), circular plasmid DNA, linear IVT-template DNA and therapeutic recombinant proteins. Biomay operates a dedicated mRNA Competence Center for cGMP manufacturing and QC testing of mRNA drug substance and drug product (clinical, commercial). The company's scope of services comprises process and analytical development, cell banking, R&D material supply, cGMP manufacturing, lipid nanoparticle / LNP formulation and aseptic filling. Biomay's facilities are inspected by the US FDA.
Associated Press
29-04-2025
- Business
- Associated Press
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.
