27/04/23 - Cytiva and the University of Adelaide are collaborating with BioCina, an Australian-based multi-product biologics contract development and manufacturing organization (CDMO), to expand its facility in Adelaide to manufacture mRNA-based vaccines and therapies. Fellow Danaher operating companies Precision NanoSystems (PNI) and the life sciences business of Pall are also contributing their technologies to complete the workflow.
This is the company’s first facility in Australia to support GMP manufacturing process from in vitro transcription (IVT) to encapsulated mRNA. Coupled with BioCina’s existing pDNA services, the new mRNA GMP capabilities will establish BioCina as Australia’s first CDMO that can support the manufacturing processes for pDNA, mRNA, encapsulations, and formulations.
Mark W. Womack, CEO, BioCina, says: “We offer comprehensive supply services to biopharmaceutical customers from early-phase clinical trials to commercial production. Cytiva’s ‘from discovery to delivery’ approach perfectly echoes BioCina’s commitment to supporting our customers by providing efficient and cost-effective solutions for developing their programs as they advance towards approval and ultimately to the patients who are waiting.”
Jon Ince, General Manager, Commercial, Australia and New Zealand, Cytiva, says: “While Australia has a highly regarded clinical trials network, and proven track record of R&D collaborations, regional manufacturing capabilities are lagging behind other developed nations, as reported in Cytiva’s 2021 Global Biopharma Resilience Index. At Cytiva we are dedicated to supporting the growth of biotherapeutic manufacturing capabilities through collaborations like these with the University of Adelaide and BioCina. This supports our vision in which access to life-changing therapeutics transforms human health.”
The complete mRNA workflow is supported by the following technologies:
At the discovery and process development stage, Cytiva provides instruments from the ÄKTA range supporting chromatography and filtration instruments, with PNI supplying key mRNA encapsulation instruments NanoAssemblr Spark, Ignite, and Blaze.
For clinical and commercial manufacture, BioCina will use Cytiva’s mRNA FlexFactory platform that includes the latest single-use manufacturing equipment and PNI’s NanoAssemblr instruments. The mRNA FlexFactory platform will bring quality, stability, efficiency, yield of mRNA products and lower the barrier to develop these new vaccines and therapies.
PNI’s Genetic Medicine Toolkit, including its proprietary GenVoy LNP delivery platform and NanoAssemblr microfluidic-based nanoparticle platform, complete the full mRNA development and manufacturing workflow that enables BioCina to rapidly develop genetic medicines of the future.
Cytiva Australia leadership team visit BioCina manufacturing site in Adelaide
BioCina Pty Ltd. is a multi-product biologics contract development and manufacturing organization (CDMO), focused on the development and cGMP manufacture of microbial-based biological pharmaceuticals, including proteins, pDNA, mRNA, vaccines and biosimilars, from early development through to commercialization. The BioCina Adelaide facility, formerly the Pfizer/Hospira plant, has a physical footprint of almost 60,000 ft2 for GMP manufacturing, process development, warehouse, and administration. The team has over 35 years of experience and extensive capabilities in microbial process development and manufacturing, with expertise from early process development to commercial manufacturing. BioCina has an enviable history manufacturing biological products approved for commercial use by the US-FDA, EMA, and Health Canada, including the manufacturing of API for use in all stages of clinical trials. Licensed for GMP manufacture by the Australian Therapeutic Goods Administration (TGA), BioCina is the only GMP manufacturing facility of its kind in Australia that has successfully passed a US-FDA inspection. BioCina is a Bridgewest Group portfolio company.
At Cytiva, we believe the key to transforming human health is accessing life-changing therapies. That’s why our nearly 10 000 associates in more than 40 countries are keenly focused on helping researchers, biopharma companies, and drug manufacturers to advance and accelerate therapeutics for people that need them. We’re driven by their desire to achieve better flexibility, capacity, and efficiency in all facets of their work – all the way from discovery to delivery.
Learn more at cytiva.com
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