Cytiva and the University of Adelaide are collaborating with BioCina, an Australia-based multi-product biologics contract development and manufacturing organisation (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.
BioCina will use Cytiva’s mRNA FlexFactory platform
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 of BioCina, said: “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.”
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
- Jon Ince, General Manager for Commercial in Australia and New Zealand at Cytiva
Jon Ince, General Manager for Commercial in Australia and New Zealand at Cytiva, added: “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, which 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
