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Biologics down under
BRISBANE, Australia—DSM Biologics, the University of Queensland's Australian Institute for Bioengineering and Nanotechnology and the state government are working together to get Australia's largest biologics scale-up facility off the ground in Brisbane.
In December, DSM Biologics and the University of Queensland's Australian Institute for Bioengineering and Nanotechnology (AIBN) signed a memorandum of understanding securing the arrangement between the two parties.
The collaboration involves the development of biologics at a $65 million scale-up facility currently under construction at the Princess Alexandra Hospital, next to the Translational Research Institute.
The collaboration makes it possible for both development and potential large-scale commercial production of the experimental Hendra virus antibody, among other therapeutics, in Queensland.
Under the arrangement, the Queensland government entity Biopharmaceuticals Australia will own the facility, which will be run by DSM Biologics, with the AIBN collaborating on early-stage biologics development. The new facility will give preferential access to Australian firms, including the AIBN, for the manufacturing of biologics, a key motivator for the Queensland and federal governments to sign on to the project. The Queensland and federal governments are contributing $7 million and $10 million respectively in seed funding for the project.
David Hughes, CEO of Biopharmaceuticals Australia, says the overall aim of the collaboration is to address a lack of biologics manufacturing capacity in the country. With no contract manufacturing organization (CMO) in the country able to take local-origin products generated in mammalian cell cultures, there has been a resulting outflow of funds from Australian biopharma drug developers to overseas CMOs.
Queensland Premier Anna Bligh points out that around $60 million currently goes offshore to small-scale drug and therapeutic manufacturers, but that's all set to change.
"This represents the final steps to ensuring that Queensland is able to seamlessly take research into new human therapeutics through to human clinical trials and subsequent production," she says.
For DSM, the facility will form an important component of its CMO strategy, enhancing its ability to serve clients at all phases of commercialization and development. In addition to early-stage biologics development, the collaboration will also focus on cell line generation, says DSM Biologics President Karen King.
"The expertise at AIBN is very complementary to DSM's skills," adds King. "The AIBN has world-class experience in mammalian cell line development."
According to King, the AIBN will collaborate with DSM on several levels, including assisting with cell line construction, process development and some technical backup for more challenging client projects.
King adds that the collaboration is an important building block for "our offering for the Australian biotech community. All important process steps can be served locally, which is important with respect to communication and speed."
King says DSM Biologics intends to start with the first projects in the first half of this year and it will be ongoing after the manufacturing plant is operational.
"The goals are to have a outstanding service offering for the customers, making use of the professional skill set of both parties," she concludes.
AIBN Director Prof. Peter Gray agrees the AIBN and DSM Biologics have a great deal of complimentarily expertise, with DSM being an expert in a number of biologics technologies. Moreover, Gray says collaboration is a fitting recognition of the skill base and facilities that had been developed in Queensland.
"AIBN researchers have developed novel high speed methods for rapidly developing the cell lines and bioprocesses needed to produce the next generation of biologics," Gray says. "The collaboration will ensure that Australian bioresearchers will be able to rapidly progress their therapeutic leads into high purity material ready for evaluation in the clinic."