2024年9月11日,江苏申基生物科技有限公司海外子公司Areterna LLC宣布,正式与奥地利维也纳CDMO公司Biomay AG达成战略合作。双方将依托各自优势和资源,共同服务于欧洲和北美的mRNA CDMO客户。本次合作是申基生物国际化战略的重要里程碑,申基生物致力于为全球提供优质的mRNA疫苗/药物原料,促进mRNA疗法研发和商业化。
May Guo
CCO of Areterna 表示
“Biomay是一家经验丰富的CDMO公司,在mRNA、质粒DNA和重组蛋白的GMP级生产方面拥有专业技术。成立40年来,Biomay拥有超过15年的GMP生产经验。我们非常高兴能与像Biomay这样的CDMO公司合作,此次合作,欧洲和美国的客户将能够使用Areterna’s性价比高且无专利费用的帽类似物、修饰核苷酸、核苷酸等mRNA原料。在Areterna原材料的助力下,Biomay可以为客户带来更多的价值。”
Hans Huber
CEO of Biomay 表示
“通过此次合作,Biomay将从Areterna在mRNA设计、LNP配方、工艺开发和分析方法开发等的丰富经验中获益。Areterna不仅仅是一家原料供应商,且拥有自己的mRNA 疫苗开发经验,我们可以利用Areterna丰富的项目经验来帮助我们的mRNA客户,解决上游工艺问题或开发特定的分析方法。最近,Biomay利用Areterna的各种Cap类似物完成了一批cGMP mRNA的批次,在性能、产量和质量方面,我们都非常满意。”
About Areterna LLC
Areterna LLC (www.areterna.com) was founded in 2023 as a wholly owned subsidiary of Synthgene Biotechnology Co., Ltd. to serve customers in the US and Europe. Synthgene provides materials and services to support mRNA and oligonucleotide manufacturing. Founded in 2018 by a group of passionate nucleic acid chemists, the goal of the company is to debottleneck the raw material supply and develop innovative solutions to support customers in the industry. The company has a robust quality system and ISO9001 certification to support cGMP manufacturing of mRNA raw materials that include NTPs, modified NTPs and cap analogs. For the GMP raw materials, Drug Master Files have been filed with FDA. In addition, Synthgene offers analytical development service and mRNA-related impurity standards and detection kits, LNP screening service, IVT process development and IVT kits for mRNA research. For solid-phase DNA and RNA synthesis, Synthgene offers high quality phosphonamidites to support cGMP oligo manufacturing. With over 200 scientists in R&D and AI-assisted discovery platform, Synthgene will continue to bring new products to the market.
About Biomay AG
Biomay AG (www.biomay.com) 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 in E. coli has 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 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 comprise process and analytical development, cell banking, R&D material supply, cGMP manufacturing and aseptic filling. Biomay´s facilities are inspected by the US FDA.
申基产品
SYNTHGENE PRODUCTS
申基生物可提供mRNA体外合成所需要的帽类似物、特殊修饰的NTPs、NTPs,分子诊断与测序所需要的dNTPs和ddNTPs,小核酸药物原料所需要的核苷、亚磷酰胺单体以及递送系统原料等。
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