Alchemia's synthetic heparin completes pilot scale process

The first batch of Brisbane biopharma Alchemia's (ASX:ACL) synthetic heparin has completed purification -- the final stage of the pilot scale process development -- at the US facilities of the company's manufacturing partner, The Dow Chemical Company.

In November 2005, Alchemia announced that its first batch of synthetic heparin - an anti-clotting agent - had been completed. The remainder of the pilot scale synthesis batches were finished in December, demonstrating successful commercial scale up.

"What we've done previously is manufacture in the lab," said Alchemia's CFO Chris Neal. "The first stage was: can we manufacture at a commercial scale? We proved that in November. The second stage is: can you now ensure that that is at the right quality and at the best possible yields for a competitive product? So that's what we've done."

Purification was expected to be completed by the end of Christmas, said Neal, and therefore took longer than originally anticipated. "What has happened in the last two months has been this finetuning," said Neal. "It is a lengthy manufacturing timescale, in excess of 12 months. The purification in reality is a relatively small bit at the end of [the manufacturing process], albeit extremely important because that's where you get your products yields and product quality."

The purification process will be used in the drug's commercial manufacture, which is scheduled to commence later in 2006.

"When commercial production starts during this year, we now know precisely how we will make it," said Neal.

The material produced in the pilot scale manufacture will now be delivered to Alchemia's marketing partners American Pharmaceutical Partners (APP), who will lodge an abbreviated new drug application with the US FDA this year, with a product expected to be launched in the US towards the end of the 2008 financial year.