BioCina, a leading contract development and manufacturing organization (CDMO) is pleased to announce that it has been awarded a $3.0M AUD grant under the Federal Government’s Cooperative Research Centres Projects (CRC-P) Grants scheme to fund work with its industry partners to further develop RNA vaccines and therapeutics.
The grant has been awarded by the Australian Government Department of Industry, Science, Energy and Resources and supports a three-year collaborative project with a total value of over $11.9M AUD with industry and academic partners, Cytiva and the University of Adelaide.
The project, commencing in March will help BioCina address the post-pandemic mRNA demand for specific and essential attributes of new RNA products. It’s anticipated the market will prioritize sophisticated LNP (lipid nanoparticle) formulations that optimize delivery and therapeutic efficacy of the mRNA cargo. There will also be increasing demand for next-generation RNA constructs such as circular RNA (circRNA) that circumvent limitations of conventional first-generation mRNA products.
BioCina will collaborate with the University of Adelaide and established industry leaders at Cytiva to address these emerging challenges. "We will determine the critical process parameters for the production of LNP-mRNA complexes using a Quality by Design (QbD) approach to develop a template of activities that can be systematically applied to any RNA molecule that a customer would require, to specifically bridge gap facing late-stage clinical trials here in Australia. Working with our industry partners, we aim to build a new expert capability to speed RNA-based product development, and to make them more stable, accelerating progress to clinical trials, for future vaccines we well as for other diseases including cancer”, said BioCina CEO Ian Wisenberg.
BioCina Chairman, Rick Hancock added “BioCina has extensive pharmaceutical development and manufacturing experience, augmented with the recent acquisition of Pfizer's facilities in Adelaide, Australia. It’s extremely exciting to be in a position to advance our expansion in this arena with such an esteemed group of experts in their field from highly respected Australian and International companies and institutions. We have state-of-the art facilities supported by our high-quality systems and standards that have allowed us to receive multiple international regulatory body approvals.”
The University’s Deputy Vice Chancellor and Vice-President (Research), Professor Anton Middelberg commented “BioCina has the only facility that currently has the registrations needed to make mRNA vaccines onshore in Australia. mRNA vaccines will impact a huge number of diseases in future, and the key will be speeding translation of discoveries from bench to market. It’s about more than just COVID.”
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. Unique to Australia, the BioCina Adelaide site is currently the only TGA, EMA, Health Canada and US-FDA approved commercial facility of its kind in Australia. BioCina is a Bridgewest Group portfolio company.