The contract development and manufacturing organization (CDMO) said the site, formerly the Pfizer/Hospira plant, has a physical footprint of almost 60,000 sq. ft. (5,574 sq. m.) for GMP manufacturing, process development, warehouse and administration. The facility provides full clinical supply services to both the pharma and biopharma sector from early-phase clinical trials to commercialization.
BioCina acquired the plant from Pfizer in August 2020.
Since transitioning from Pfizer, capabilities for the BioCina site have been expanded to now include manufacturing of GLP and, available in Q1 2022, cGMP-grade plasmid DNA (pDNA).
"We have been working hard to make sure that we hit the ground running after transitioning this facility and operations from Pfizer. The team has been working flat out to ensure that they stand up all the systems and comply with all the regulatory requirements to be fully operational. We already have several customers utilizing our services and several others, both domestic and international, in the queue. For a company starting out like BioCina, this is a very big deal," said BioCina CEO, Ian Wisenberg.
Sovereign supply of mRNA vaccines and therapeutics
The facility's capabilities, reported the CDMO, will include development and cGMP manufacture of microbial-based biological pharmaceuticals, including next-generation recombinant molecules such as antibody fragments/antibody mimetics along with bio-conjugated therapeutics like pegylated proteins and polysaccharide-conjugated vaccines, enzymes, and fusion proteins.
It will also provide full production of biosimilars along with mRNA vaccines to drug substance, with the CDMO looking to add capabilities for encapsulation using lipid nanoparticles in the near future.
The organization maintains it can support the Australian government’s goal of ensuring sovereign supply of mRNA vaccines and therapeutics.
"The company's investment in this facility brings new capabilities to South Australia to support the production of mRNA vaccines, CAR-T cell therapies and viral gene replacement therapies," commented commented Stephen Patterson, minister for trade and investment, South Australian government.