OTS - Biomay Announces Expansion of GMP-Facilities to Offer mRNA Manufacturing and Aseptic Filling Services
2023. November 13. 14:47
Vienna, 13 November, 2023 (APA/OTS) - 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.
Picture is available at website:
http://ots.mti.hu/Pages/Picture.aspx?fi=OTS_20231113_001.jpg
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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