Progen teams with CSIRO in manufacturing deal

Australia's largest contract drug manufacturer, Progen Industries, and CSIRO are marrying their bio-manufacturing skills.

They have signed a memorandum of understanding to combine Progen's later-stage manufacturing strengths with the early-stage processing skills of CSIRO's fermentation and bioprocessing group.

The partnership projects a broader, stronger manufacturing capability that is expected to help win business from North America biotechs among whom Progen is already scoring successes.

Since showcasing its manufacturing capability at Bio 2002 in Toronto, Progen has attracted increasing attention from potential US customers. It is currently carrying out a $500,000 contract manufacturing deal with US-based Lipid Sciences and is in serious discussions with several others, according to Progen's vice-president of business development, Dr Peter Devine.

The manufacturing alliance will concentrate initially on bacterial cultures but could be expanded in future to include mammalian cell cultures.

CSIRO Molecular Science has expertise in early-stage processes such as optimisation of fermentation conditions and purification of potential drug candidates. However, it has relatively small fermentation facilities (about 100 litres) and lacks Australian Code of Good Manufacturing Process (cGMP) certification.

Progen's 11,000 square foot manufacturing facilities are cGMP rated, its 2000 litre total fermentation capacity gives it larger scale capabilities and it also offers post-manufacturing services such as clinical trial management.

The CSIRO group is located in Melbourne, while Progen is in Brisbane, but the relatively small amounts of product which will have to be shipped between the two partners will present no logistical difficulties, Devine said.

The non-exclusive pact is the first of its type that CSIRO has entered into, according to Dr Michael Zachariou, project leader with the fermentation and bioprocessing group.

"It will allow us to further expand our know-how in process development and give us access to manufacturing capacity and cGMP facilities," he said.

His group is part of CSIRO's Molecular Sciences division. It was formed 18 months ago and is made up of six scientists with backgrounds ranging from the US big pharma industry to CSL.

Financial arrangements governing the multi-year agreement were not revealed.

Progen is in Phase II clinical trials with its leading anti-cancer drug candidate, PI-88. But the new alliance demonstrates the company is keen to explore the potential of its contract manufacturing arm which contributed the bulk of the company's 46 per cent revenue rise for the half year to last December.