Gradipore touts technology's commercial potential

Sydney-based bioseparations specialist Gradipore (ASX:GDP) claims to have successfully completed proof-of-principle studies demonstrating scale-up of its Gradiflow technology to commercial levels.

The studies were carried out by Gradipore and US-based biotechnology company Serologicals Corporation. Gradipore recently acquired Serologicals' plasma therapeutics business in a deal worth around AUD$22 million.

Gradipore CEO and managing director Dr Hari Nair said the proof-of-principle study was in progress long before the two companies agreed to the buy-out. "It's independent of the Serologicals deal -- the evaluation started about 18 months ago," he said.

Essentially, the study examined the use of the Gradiflow technology to purify hyperimmune IgG from plasma. Initially carried out at an analytical scale using the Gradiflow BF-400 unit, Serologicals wanted to evaluate the process scaled up to commercial levels using the GMP-compliant production-scale GF-100 unit.

"We were asked to look at purification of a particular protein that Serologicals wanted to purify and were told that we had to show scalability of the Gradiflow technology," Nair said.

The results of the study demonstrated that the Gradiflow technology was able to purify the IgG from the plasma at a 500-fold increase in scale over the analytical-scale process, in just one step -- an improvement on standard chromatography methods that typically require three to five steps. The technique was shown to be robust and reproducible, according to Nair, and produced higher yields in less time.

The result provides necessary validation of Gradipore's technology, as the company restructures itself around the use of the Gradiflow technology going forward. Gradipore intends to use the separations method to purify proteins from plasma for therapeutic uses, and through its deal with Serologicals has secured a source of plasma for that purpose.

Nair said the company is also interested in forming joint ventures with other companies to develop the Gradiflow technology for particular applications.

At the time of writing, Gradipore's shares were trading 6.25 per cent higher at AUD$0.68.