Biomay Announces Expansion of GMP-Facilities to Offer mRNA Manufacturing and Aseptic Filling Services for Clients

Biomay AG, a fully integrated Contract Development and Manufacturing Organization (CDMO), have announced the expansion of their biomanufacturing facility in Vienna, Austria. The upgraded site will serve as their Center of Excellence for end-to-end services, specifically for messenger RNA (mRNA) manufacturing.

The new facility in Vienna’s 9th district will feature clean rooms, laboratories, and warehouse premises, and will span 2000 sqm. It will be equipped with five GMP-commissioned clean rooms for upstream and downstream processing and aseptic filling, as well as comprehensive laboratories for quality control, process and assay development.

Biomay will use cutting-edge enzymatic run-off transcription based on linear DNA templates for mRNA processing, offering various options for 5´-capping, 3´-poly-adenylation, and nucleotide modification as per client requirements.

This addition to their main site in Vienna Seestadt (22nd district, Ada Lovelace-Strasse) comes after the company supplied significant amounts of linear DNA templates during the COVID-19 pandemic for the manufacturing of a COVID-19 mRNA vaccine. They have also gained experience in GMP manufacturing of DNA templates for other clinical indications, such as oncology.

The upgraded site’s aseptic filling capacities include a seven-glove isolator equipped with an automated processing line for aseptic filling, vial capping and crimping, primarily serving clinical-stage investigational medicinal products (IMPs).

Dr. Angela Neubauer, Biomay’s Senior Vice President Client Business and Site Head of the facility, commented on the company’s evolution: “We are proud to have developed from being a drug substance and API manufacturer to offering drug product aseptic filling, testing and release services. We are now looking to become a leading player in the mRNA CDMO field, alongside our existing expertise in proteins and plasmids.”

Founded in 1984, Biomay AG are a fully integrated CDMO with a focus on microbial based GMP services for manufacturing therapeutic proteins, plasmid DNA and mRNA.

Dr. Angela Neubauer, Biomay AG’s Senior Vice President Client Business, said: “We are proud to have developed from being a drug substance and API manufacturer to offering drug product aseptic filling, testing and release services. We are now looking to become a leading player in the mRNA CDMO field, alongside our existing expertise in proteins and plasmids.”

Biomay AG, a fully integrated Contract Development and Manufacturing Organization (CDMO), have announced the expansion of their biomanufacturing facility in Vienna, Austria. The new facility in Vienna’s 9th district will span 2000 sqm and will serve as their Center of Excellence for end-to-end services, specifically for messenger RNA (mRNA) manufacturing.

The upgraded site will feature clean rooms, laboratories, and warehouse premises, and will be equipped with five GMP-commissioned clean rooms for upstream and downstream processing and aseptic filling, as well as comprehensive laboratories for quality control, process and assay development. Biomay will use cutting-edge enzymatic run-off transcription based on linear DNA templates for mRNA processing.

The new site complements Biomay’s main manufacturing site in Vienna Seestadt (22nd district, Ada Lovelace-Strasse), which was established in 2021. Notably, Biomay has a strong track record in GMP production of linear DNA templates, supplying significant amounts of these templates during the COVID-19 pandemic for the manufacturing of a COVID-19 mRNA vaccine. They have also gained experience in GMP manufacturing of DNA templates for other clinical indications, such as oncology.

The upgraded site’s aseptic filling capacities include a seven-glove isolator equipped with an automated processing line for aseptic filling, vial capping and crimping, primarily serving clinical-stage investigational medicinal products (IMPs).

Dr. Angela Neubauer, Biomay AG’s Senior Vice President Client Business, said: “We are proud to have developed from being a drug substance and API manufacturer to offering drug product aseptic filling, testing and release services. We are now looking to become a leading player in the mRNA CDMO field, alongside our existing expertise in proteins and plasmids.”

Founded in 1984, Biomay AG are a fully integrated CDMO with a focus on microbial based GMP services for manufacturing therapeutic proteins, plasmid DNA and mRNA.

Biomay AG have announced the expansion of their biomanufacturing facility in Vienna, Austria. The new facility in Vienna’s 9th district will span 2000

Derick is an experienced reporter having held multiple senior roles for large publishers across Europe. Specialist subjects include small business and financial emerging markets.

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