BioPharmaceuticals Australia (BPA) told BioPharma-Reporter.com it has launched a Biopharmaceutical Development Fund (BDF) in the face of “a national capability gap” to support the development of therapeutic proteins from preclinical stage through to approval.
BPA’s AUS$65m US$61m) facility in Brisbane, Australia, which is operated by Patheon Biologics under a long-term lease, manufactures cell culture-derived active pharmaceutical ingredients (APIs) for preclinical and clinical trials, as well as for the commercial market.
Patheon Biologics will manufacture cell lines for the companies which receive BPA grants, Patheon Biologics’ VP of Marketing and Sales, Marc Goemans, told BioPharma-Reporter.com.
To qualify for the grants, available over a two-year period, organisations must demonstrate “a validated mechanism of action for a well-characterised biologic molecule and genuine need for financial support.”
Australia’s ‘capability gap’
The contract manufacturing plans were part of the original agreement for building the facility, according to BPA.
“The facility was an initiative by Australia’s Queensland State Government, supported by the Federal Government, to fill a national capability gap. By establishing mammalian cell based contract manufacturing services in Australia, local biotherapeutic developers would no longer need to go offshore,” said Brett Whitecross, BPA Business Development Manager.
“The program is partially modeled on a past Australian Federal Government program that proved highly successful,” Whitecross told BioPharma-Reporter.com. “That program financially supported access to a range of national facilities providing biotechnology development services for biotherapeutic developers.”
BPA said there is scope to increase funding and expand the program in the future if this pilot is successful.
The aim of the manufacturing fund, BPA said in a statement, is to increase the number of Australian-made and clinically trialled biopharmaceutical products, and to attract international biotechnology companies to set up local subsidiaries and work with Patheon Biologics.
The move will strengthen Queensland and Australia’s reputation as a biotechnology development hub, according to BPA, which added it would leverage Australia’s Clinical Trial Notification (CTN) Scheme and R&D Tax Incentive to try to attract international drug developers to manufacture in Queensland.
The programme will reduce the risk of expensive GMP manufacturing being delayed by cash problems for small, financially constrained biotech companies, said BPA.
The grants aim to accelerate biologics’ route to the commercial market by co-funding access to “pivotal” process developmental, scale-up and GMP manufacturing activities.