Biologics down under

BRISBANE, Australia—DSM Biologics, the University ofQueensland's Australian Institute for Bioengineering and Nanotechnology and thestate government are working together to get Australia's largest biologicsscale-up facility off the ground in Brisbane.

In December, DSM Biologics and the University ofQueensland's Australian Institute for Bioengineering and Nanotechnology (AIBN)signed a memorandum of understanding securing the arrangement between the twoparties.

The collaboration involves the development of biologics at a$65 million scale-up facility currently under construction at the PrincessAlexandra Hospital, next to the Translational Research Institute.

The collaboration makes it possible for both development andpotential large-scale commercial production of the experimental Hendra virusantibody, among other therapeutics, in Queensland.

Under the arrangement, the Queensland government entityBiopharmaceuticals Australia will own the facility, which will be run by DSMBiologics, with the AIBN collaborating on early-stage biologics development.The new facility will give preferential access to Australian firms, including theAIBN, for the manufacturing of biologics, a key motivator for the Queenslandand federal governments to sign on to the project. The Queensland and federalgovernments are contributing $7 million and $10 million respectively in seedfunding for the project.

David Hughes, CEO of Biopharmaceuticals Australia, says theoverall aim of the collaboration is to address a lack of biologicsmanufacturing capacity in the country. With no contract manufacturingorganization (CMO) in the country able to take local-origin products generatedin mammalian cell cultures, there has been a resulting outflow of funds fromAustralian biopharma drug developers to overseas CMOs.

Queensland Premier Anna Bligh points out that around $60million currently goes offshore to small-scale drug and therapeuticmanufacturers, but that's all set to change.

"This represents the final steps to ensuring that Queenslandis able to seamlessly take research into new human therapeutics through tohuman clinical trials and subsequent production," she says.

For DSM, the facility will form an important component ofits CMO strategy, enhancing its ability to serve clients at all phases ofcommercialization and development. In addition to early-stage biologicsdevelopment, the collaboration will also focus on cell line generation, saysDSM Biologics President Karen King.

"The expertise at AIBN is very complementary to DSM'sskills," adds King. "The AIBN has world-class experience in mammalian cell linedevelopment."

According to King, the AIBN will collaborate with DSM onseveral levels, including assisting with cell line construction, processdevelopment and some technical backup for more challenging client projects.

King adds that the collaboration is an important buildingblock for "our offering for the Australian biotech community. All importantprocess steps can be served locally, which is important with respect tocommunication and speed."

King says DSM Biologics intends to start with the firstprojects in the first half of this year and it will be ongoing after themanufacturing plant is operational.

"The goals are to have a outstanding service offering forthe customers, making use of the professional skill set of both parties," sheconcludes.

AIBN Director Prof. Peter Gray agrees the AIBN and DSMBiologics have a great deal of complimentarily expertise, with DSM being anexpert in a number of biologics technologies. Moreover, Gray says collaborationis a fitting recognition of the skill base and facilities that had beendeveloped in Queensland.

"AIBN researchers have developed novel high speed methodsfor rapidly developing the cell lines and bioprocesses needed to produce thenext generation of biologics," Gray says. "The collaboration will ensure thatAustralian bioresearchers will be able to rapidly progress their therapeuticleads into high purity material ready for evaluation in the clinic."