Expanded facility to manufacture mRNA-based therapies and vaccines 

Researchers at the University of Adelaide will address the design and manufacturing of lipid  nanoparticles (LNP) that help deliver mRNA into cells

perating 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.