(SAN DIEGO and ADELAIDE, November 30, 2021) BioCina, a leading contract development and manufacturing organization (CDMO) specializing in process development and cGMP manufacturing of microbial-based therapeutics and mRNA vaccines announces the official opening of its new biologics manufacturing facility in Adelaide, Australia.
The official opening for the research, development and manufacturing biologic plant in Adelaide was performed today by South Australian Minister for Trade and Investment Stephen Patterson.
The newly repurposed 45,257 ft2 facility offers full clinical supply services to pharmaceutical and biopharmaceutical customers and specializes in services from early-phase clinical trials to commercialization.
The facility’s capabilities will include:
- Development and cGMP manufacture of microbial-based biological pharmaceuticals, including next-generation recombinant molecules such as antibody fragments/antibody mimetics
- Bio-conjugated therapeutics such as pegylated proteins and polysaccharide-conjugated vaccines, enzymes, fusion proteins, and other therapeutic proteins
- Full production of mRNA vaccines and biosimilars, from early process development through to commercial product manufacture.
BioCina's world class team leverages leading-edge technologies and processes, in combination with agile operations and extensive regulatory credentials. Since transitioning from Pfizer, capabilities for BioCina have been expanded to now include manufacturing of GLP and, available in Q1 2022, cGMP-grade plasmid DNA. BioCina is the only CDMO in the region with the capability and capacity to manufacture plasmid DNA in both a GLP and GMP environment.
In addition, to meet the unprecedented need for mRNA manufacturing capacity now and into the future, BioCina has expanded current capabilities and services to include the manufacture of mRNA vaccines to drug substance and will be adding capabilities for encapsulation using lipid nanoparticles in the foreseeable future.
“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.
"BioCina is ready to support the Australian Government and their stated desire to ensure sovereign supply of mRNA vaccines and therapeutics. This is complimentary to our core capabilities in the manufacture of microbial drug substance and vaccines," added Wisenberg.
The Minister for Trade and Investment Stephen Patterson said BioCina’s commitment to establishing its facility in Adelaide is testament to South Australia’s growing global reputation for clinical trials as part of the health and medical sector.
“I’m delighted that BioCina’s facility and world-class team are here in South Australia delivering cutting-edge technologies and processes to support the development and manufacturing of microbial-based therapeutics and mRNA vaccines,” Minister Patterson said.
“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," added Minister Patterson.
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, 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.