Biomay Announces Expansion of GMP-Facilities to Offer mRNA Manufacturing and Aseptic Filling Services
Monday 13 November, 2023
Biomay expanded its biomanufacturing facility in central Vienna, 9th
district, by adding clean rooms, laboratories, and warehouse premises in
the Vienna Competence Center building. Besides the 4000 sqm main site in
Vienna 22nd district, Biomay now operates an additional 2000 sqm
integrated biomanufacturing facility, equipped with five
GMP-commissioned clean rooms for upstream and downstream processing and
aseptic filling. Furthermore, the site features comprehensive
laboratories for quality control, process and assay development.
A New Center of Excellence for mRNA
The upgraded site will serve as Biomay's Center of Excellence for
end-to-end Contract Development and Manufacturing Organization (CDMO)
services, specifically for messenger RNA (mRNA) manufacturing. The GMP
service offerings for mRNA include plasmid cell banking, circular
plasmid and linear DNA template manufacturing, in-vitro transcription
(IVT) of mRNA drug substance, and aseptic filling of mRNA drug product.
Biomay employs 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.
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.
The company has also gained extensive experience in GMP manufacturing of
DNA templates for other clinical indications, such as oncology.
Aseptic Filling Capacities
Biomay'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, the Site Head of the
facility and Biomay's Senior Vice President Client Business, emphasized
the company's evolution from being a drug substance and API manufacturer
to offering drug product aseptic filling, testing and release services.
She highlighted Biomay's strategic goal of establishing itself as a
leading player in the mRNA CDMO field, alongside its existing expertise
in proteins and plasmids.
About Biomay
Founded in 1984, Biomay AG is a fully integrated CDMO with a focus on
microbial based GMP services for manufacturing therapeutic proteins,
plasmid DNA and mRNA. The new site complements Biomay’s main
manufacturing site in Vienna Seestadt (22nd district, Ada
Lovelace-Strasse), established in 2021.Contact:
Dr. Angela Neubauer, SVP Client Business, request@biomay.com
Biomay AG / Ada Lovelace-Str. 2, A-1220 Vienna, Austria, www.biomay.com
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