BioCina

BioCina is a global end-to-end biologics contract development and manufacturing organization (CDMO) specializing in microbial, plasmid DNA (pDNA), and messenger RNA (mRNA) modalities. The company operates from a 45,257 square-foot facility in Adelaide, Australia, which was formerly owned by Pfizer. BioCina acquired this facility in August 2020 and gained full operational control in October 2021. The facility is equipped with state-of-the-art cGMP capabilities, including cell banking suites, fermentation equipment, and purification systems. BioCina offers a range of services including cell line development, process development, and cGMP clinical and commercial manufacturing solutions.

The company's Adelaide facility is approved by regulatory agencies including the US FDA, European Medicines Agency (EMA), Health Canada, and the Australian Therapeutic Goods Administration (TGA). It is Australia's only bacterial cell-based facility that meets regulatory criteria for medicinal products. BioCina has expanded its capabilities to include the manufacture of cGMP-grade plasmid DNA using a 750 L microbial fermenter, supporting new modalities such as mRNA vaccines, CAR-T cell therapies, and viral gene replacement therapies. In April 2023, BioCina was awarded a USD 5 million AUD grant from the Australian Government's Medical Research Future Fund to develop enabling technologies for the manufacture of precision mRNA vaccines.

Key customers and partnerships

BioCina has established partnerships with several companies and organizations in the biopharmaceutical industry. In November 2023, BioCina expanded its partnership with GPN Vaccines Ltd. to manufacture large-scale cGMP batches for GPN's Gamma-PN vaccine against Streptococcus pneumoniae. In October 2023, BioCina partnered with GenomeFrontier Therapeutics to support the development of innovative virus-free chimeric antigen receptor T cell products (CAR-T) for cancer treatment, providing process development and GMP manufacturing for Minicircle DNA and Plasmid DNA.

In March 2024, BioCina announced a partnership with NovaCina, a global fill-and-finish CDMO, to offer integrated drug substance and drug product solutions for biologics developers. This collaboration aims to provide end-to-end biopharmaceutical manufacturing solutions, allowing BioCina to offer fill/finish services while converting drug substances produced at its Adelaide facilities into drug products at NovaCina's facilities in Perth, Australia. Additionally, in June 2024, BioCina acquired the exclusive CDMO rights to utilize CelluTx's Recombination Based Plasmid System (RBPS) technology for minicircle DNA production, further expanding its capabilities in advanced therapeutics manufacturing.