CDMO Biomay said its upgraded site will offer mRNA manufacturing services, including aseptic filling of mRNA drug product.
Contract development manufacturing organization (CDMO) Biomay announced plans to construct a biomanufacturing facility in central Vienna, Austria in December 2020. The firm then acquired additional clean room, laboratory and warehouse space in the Vienna Competence Center building earlier this year and has transformed this into 2000 square meters of floor space.
As a result of the expansion, the CDMO now offers its clients messenger RNA (mRNA) services, which includes circular plasmid and linear DNA template production, in-vitro transcription (IVT) of mRNA drug substance and aseptic filling of mRNA drug product. Biomay said the production activities are supported by a quality control laboratory that has specific analytical assays and a team focused on manufacturing science and technology (MSAT).
Image c/o Biomay
Additionally, the expanded site consists of five GMP-commissioned cleanrooms for both upstream and downstream processing, as well as aseptic filling. Additionally, there are laboratories used for quality control, process, and assay development.
“The success of mRNA vaccines (Covid, infectious diseases) and new mRNA vaccine developments in cancer therapy has risen the demand for mRNA related GMP services. There are not many CDMOs offering mRNA manufacturing. Since Covid, Biomay has been already supplying DNA templates for mRNA-In vitro transcription (e.g., for BioNTech). Manufacturing mRNA itself and aseptic filling considerably extends our scope of services,” a spokesperson for Biomay told BioProcess Insider.
In October, MilliporeSigma – the life sciences division of Germany’s Merck KGaA – opened two mRNA drug substance manufacturing facilities in Darmstadt and Hamburg, Germany. In turn, the CDMO said it was the first to offer integrated services for all stages of mRNA development, production, commercialization, and testing.
While the spokesperson said financial details will not be disclosed, he told us the main reason Biomay decided to make this investment is “not because other CDMOs invested in biotech manufacturing” but because of the “increasing demand in mRNA services.”
However, he added how Biomay is facing “increased competition in the CDMO market, especially in the plasmid manufacturing field” and said, “it was self-evident for Biomay to also provide mRNA serves as another key nucleic acid product.”
The facility is “up and running” but full capacity will be completed in the first quarter of 2024. No financial results Facility is up and running, and the first mRNA GMP batches are ongoing these days. The ramp up of full capacities will be finished in Q1/2024
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