BioCina to expand mRNA vaccines capabilities

Biotechnology company BioCina is expanding the capabilities of its Australian biologics facility (pictured), broadening its capabilities to manufacture mRNA-based vaccines and therapies.

The factory, formerly owned by vaccines manufacturer Pfizer, is to employ a range of technologies from associated companies Cytiva and others associated with American medical group of companies Danaher, as well as collaborater the University of Adelaide.

Investment company Bridgewest agreed to buy the Adelaide plant in 2020, the same year the site was approved by the US Food and Drug Administration (FDA) for commercial manufacturing.

The facility has more than 35 years of microbial fermentation experience and over the past 15 has worked on over 50 different products and has partnered with more than 30 customers globally.

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, according to the company.

CEO of BioCina Mark W. Womack 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 programmes as they advance towards approval and ultimately to the patients who are waiting.”

General Manager, Commercial, Australia and New Zealand of Cytiva Jon Ince said Australia had a highly regarded clinical trials network, and proven track record of R&D collaborations.

However manufacturing capabilities were lagging behind other developed nations.

Ince said: “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.”

According to BioCina, the complete mRNA workflow for the facility 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
• And 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.

Picture: BioCina