DSM's cGMP biologics plant a boon to Australian biotech, firm says

30-Oct-2013 - Last updated on 30-Oct-2013 at 13:14 GMT

DSM Biologics officially opens its Australian Government funded plant

DSM says its new biomanufacturing facility will benefit the Australian biotech sector, overcoming the problems of distance with foreign contract manufacturers.

The Brisbane, Australia plant has been operational since June this year, but DSM Pharmaceutical Products officially opened its plant today to coincide with the AusBiotech show.

The 70,000 sq ft plant was conceived in a joint venture with the Australian Government in 2010, in order to fill a cGMP gap in a growing local biotech sector and, according to Marc Goemans, VP Global Marketing & Sales at DSM Biologics, this is still the only plant offering this.

He told Biopharma-Reporter.com: “There are small CROs providing clinical material on a non-GMP basis, but we’re the only cGMP contract manufacturing facility in Australia.”

He continued, adding this was a “huge deal” for both DSM and the Australian biopharma industry. Before this plant, the only option was for biotech firms to contract their manufacturing needs overseas in Europe and the US.

When dealing with a biologics contract manufacturer, Goemans said there is a large amount of interaction and an eight or nine hour time difference is a big hindrance. A CMOs “proximity is a huge driver for biomanufacturing,” more so than the cost of transporting biologics, for example.

Located within the Queensland Translational Research Institute (TRI) - designed to be a one-stop shop for discovery, production and clinical testing of biologics - the plant was built with capital from the Australian Government and the technical expertise of DSM.

Described by the firm as the blueprint for its 'biologics plant of the future,' the facility’s flexible design and single-use technology offers mammalian cell-based manufacturing of biopharmaceuticals using DSM’s proprietary XD cell culture technology and its Rhobust direct capture downstream technology.

The site has an output capability of 500kg with expansion space available. It was inspected by the Australia’s regulators the TGA (who have an agreement with the US Food and Drug Administration) earlier this year and Goemans expected it to pass with operations commencing in January 2014.

Contracts

So far, three deals have been announced at the new facility though Goemans said DSM has other contracts which are yet to be divulged from both local and international firms, looking to take advantage of the facility and Australian tax incentives.

A fourth contract was announced today with Australian firm Opthea and DSM is set to develop and manufacture the firm’s lead molecule, a soluble form of human VEGFR-3 that blocks the activity of both VEGF-C and VEGF-D, from the Brisbane site.

Furthermorem Goemans added, some of DSM’s projects currently undertaken at its Dutch facility will be transferred to the new site in order to benefit from larger capacity and larger scale manufacturing.