Collaboration expands Areterna’s reach in Europe and strengthens Biomay’s mRNA CDMO offerings.
Gaithersburg, MD and Vienna, Austria (September 18, 2024) — Areterna LLC, a company with a mission to democratize mRNA products by supplying low-cost GMP raw materials, today announced it has entered a strategic partnership with Biomay, a seasoned CDMO that offers GMP manufacturing of mRNA, plasmid DNA and recombinant proteins.
This partnership will allow European and American customers access to Areterna’s low-cost and royalty-free cap analogs as well as animal-origin-free nucleoside triphosphates (NTPs) and modified NTPs. “Biomay is a CDMO we admire. Established for 40 years, it has more than 15 years of GMP manufacturing experience. Biomay has manufactured hundreds of GMP batches including not only clinical but also commercial products,” said May Guo, Chief Commercial Officer of Areterna. “It’s a pleasure to work with a high-caliber CDMO like Biomay. Customers will have peace of mind by working with a site that recently has passed FDA inspection. With the help of Areterna´s raw materials, Biomay can bring more value to its customers.”
Through the partnership, Biomay will profit from Areterna’s expertise in mRNA design, LNP formulation, process development and analytical development. “Areterna is more than a raw material supplier. The company has its own veterinary mRNA vaccine pipeline. By developing its own mRNA vaccines, Areterna has built its expertise in mRNA and LNP manufacturing, QC analysis and functional testing,” said Hans Huber, Chief Executive Officer of Biomay, “We can leverage Areterna’s expertise in helping our mRNA customers such as trouble shooting the upstream process or developing construct specific analytical methods. Biomay has recently finalized a number of cGMP mRNA batches by utilizing various cap analogs from Areterna. We are highly satisfied in terms of performance, yield and quality.”
The companies see they complement each other in skill sets and can jointly serve mRNA customers better.
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.
Media Contact:
Tel: 240-406-1859
Email: info4@areterna.com
Web: www.areterna.com
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.
Media Contact:
Dr. Hans Huber, Chief Executive Officer
info@biomay.com / media@biomay.com
Biomay AG, Ada Lovelace-Str. 2, A-1220
Vienna, Austria