{"id":61382,"date":"2025-05-09T11:59:51","date_gmt":"2025-05-09T09:59:51","guid":{"rendered":"https:\/\/ticker-noticiasep.microcontenidos.com\/NoticiaRSS.vbhtml?user=FRND562DLP&amp;cod=20250509115951"},"modified":"2025-05-09T11:59:51","modified_gmt":"2025-05-09T09:59:51","slug":"mundo-biomay-launches-fda-grade-crispr-cas9-nuclease-for-off-the-shelf-purchase","status":"publish","type":"post","link":"https:\/\/webciudadana.net\/?p=61382","title":{"rendered":"Mundo: Biomay Launches FDA-Grade CRISPR\/Cas9 Nuclease for Off-the-Shelf Purchase"},"content":{"rendered":"\n<p>(Informaci\u00f3n remitida por la empresa firmante)<\/p>\n<p>\nVienna, Austria \u2013 May 9th 2025 \u2013 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.<\/p>\n<p> 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.<\/p>\n<p> Biomay\u2019s Cas9 (internal code \u201cBMC9\u201d) is based on the classical wild-type Cas9 nuclease from Streptococcus pyogenes. The Cas9 manufacturing process has been de novo developed, GMP-implemented and PPQ-validated by Biomay. GMP and RUO manufacturing is performed by fermentation with E. coli and 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.<\/p>\n<p>\n\u201cThe addition of Cas9 to Biomay\u2019s off-the-shelf portfolio aligns with our mission to provide high-quality and scalable solutions for emerging therapeutic modalities,\u201d said Dr. Hans Huber, CEO of Biomay. \u201cWith 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.<\/p>\n<p> Biomay*s latest addition further strengthens the company\u2019s 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.<\/p>\n<p> About Biomay:<\/p>\n<p>\nBiomay AG is a fully integrated Contract Development and Manufacturing Organization (CDMO) based in Vienna, Austria. Founded in 1984, the expression of recombinant proteins in E. coli has been Biomay&#8217;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&#8217;s scope of services comprises process and analytical development, cell banking, R&amp;D material supply, cGMP manufacturing, lipid nanoparticle \/ LNP formulation and aseptic filling. Biomay&#8217;s facilities are inspected by the US FDA.<\/p>\n<p> Contact:<\/p>\n<p>\nDr. Angela Neubauer, Senior Vice President Client Business; Tel.: +43-1-7966296-141; request@biomay.com<\/p>\n<p>\nBiomay AG, Ada Lovelace-Str. 2, A-1220 Vienna, Austria; www.biomay.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Informaci\u00f3n remitida por la empresa firmante) Vienna, Austria \u2013 May 9th 2025 \u2013 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 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-61382","post","type-post","status-publish","format-standard","hentry","category-noticias"],"_links":{"self":[{"href":"https:\/\/webciudadana.net\/index.php?rest_route=\/wp\/v2\/posts\/61382","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/webciudadana.net\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/webciudadana.net\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/webciudadana.net\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/webciudadana.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=61382"}],"version-history":[{"count":0,"href":"https:\/\/webciudadana.net\/index.php?rest_route=\/wp\/v2\/posts\/61382\/revisions"}],"wp:attachment":[{"href":"https:\/\/webciudadana.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=61382"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/webciudadana.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=61382"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/webciudadana.net\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=61382"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}