Parallel chromatography is ViroPharma's current hero. Cheered by the success of parallel chromatography in turning out its injectable drug Cinryze, the company has now asked FDA for permission to pump up its manufacturing capacity.
The company needs the FDA's blessing; industrial-scale production of Cinryze has to match smaller-scale manufacturing's quality. In its application, ViroPharma said it aims to run multiple shifts, aiming to double capacity of its current manufacturing line.
ViroPharma says it's expecting approval during the fourth quarter of this year, with increased production hitting its numbers by early 2011. "The filing of our [application] for industrial scale manufacturing takes us one step closer toward making product at enhanced capacity available to many more patients," COO Dan Soland said in a statement. "We now have increased confidence in our goal of gaining approval for this scale-up initiative for Cinryze this year."
- see the ViroPharma release
- read the story at in-Pharma Technologist
- check out the Chromatography Today piece