Biomay Launches Fast-track Manufacturing Service for Personalized mRNA and DNA Cancer Vaccines

Press release Vienna, Austria – October 21, 2026 New service enables GMP manufacturing and quality release of patient-specific cancer vaccines in a few weeks

Biomay, a contract development and manufacturing organization (CDMO) specializing in high-quality plasmid DNA and mRNA manufacturing, is highlighting its dedicated manufacturing platform for personalized neoantigen based cancer vaccines. Designed to meet the demanding timelines of individualized cancer immunotherapies, the service enables the production of personalized DNA cancer vaccines in as little as two weeks and mRNA-based vaccines in approximately three weeks, from starting material to release.

Personalized cancer vaccines require exceptional manufacturing agility, stringent quality standards and reliable supply to support clinical development. Biomay addresses these needs through a highly efficient platform combining dedicated manufacturing suites, established GMP processes and integrated quality control capabilities.

Dedicated capacity for individualized therapies

Biomay brings nearly 20 years of GMP experience and established CDMO expertise to the manufacture of patient-specific DNA and mRNA cancer vaccines. The company´s personalized manufacturing capacities comprise a purpose-built facility of ten dedicated GMP cleanroom suites, in which meanwhile more than 120 personalized GMP-batches have been manufactured and released. The platform supports mRNA batches of up to 50 mg and DNA batches of up to 300 mg. Segregated manufacturing suites enable parallel production, with the potential to scale to several hundred GMP batches per year. The facility was successfully inspected by the U.S. FDA in 2026.

Streamlined end-to-end manufacturing from starting material to QP release

The manufacturing workflows are designed to minimize turnaround times while maintaining high batch-to-batch consistency. An important step was bringing most analytical methods in-house, including for instance LC-MS, to cut time for shipments and external lab coordination.

For personalized DNA cancer vaccines, the process progresses from starting material through DNA production and quality control to QP release in as little as two weeks. The personalized mRNA cancer vaccines workflow includes template DNA production, mRNA in-vitro transcription, lipid nanoparticle (LNP) manufacturing, quality control and QP release in approximately three weeks. Manufacturing and analytical release testing capabilities include aseptic filling and in-house rapid sterility testing, supporting an integrated approach to manufacturing and product release.

About Biomay

Biomay is a fully integrated CDMO based in Vienna, Austria. Biomay offers cGMP services for the manufacturing of mRNA, circular and linear DNA (plasmid-based or synthetic/enzymatic), and therapeutic recombinant proteins (clinical and commercial). The company’s services include process and analytical development, cell banking, R&D material supply, cGMP manufacturing, LNP formulation, and aseptic fill-finish. Biomay’s manufacturing facilities are multiple times inspected by the U.S. FDA.

Contacts:

Dr. Arnd Dankesreiter, Vice President Business Development Europe; request@biomay.com
Biomay AG, Ada Lovelace-Str. 2, A-1220 Vienna, Austria; www.biomay.com
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