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news.ViroPharma is increasing its Cinryze (C1 Esterase Inhibitor [Human]) manufacturing facility capacity through two concurrent efforts.
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The first project, the parallel chromatography process, was implemented earlier this year and allows production to run across multiple shifts, effectively doubling the capacity of the current manufacturing line and increasing the amount of drug supply available to patients suffering from hereditary angioedema, or HAE.
The addition of the industrial scale project is expected to significantly increase capacity for Cinryze, providing adequate supply to meet the company’s projected demand growth for prophylaxis against attacks of HAE.
Additionally, ViroPharma has filed a prior approval supplement (PAS) with the FDA seeking approval to commercialise Cinryze manufactured using the industrial scale process.
ViroPharma said that the supplemental data filed with the FDA include in-depth comparability testing at critical manufacturing stages from three conformance lots of industrial scale produced product, as well as stability data and lot release data.
ViroPharma believes these data demonstrate that product manufactured at industrial scale meets the required equivalence criteria compared to Cinryze manufactured at current scale.
Further, it also anticipates receiving approval for product manufactured at industrial scale in the fourth quarter of 2010. The company expects that the impact to sales from industrial scale manufacturing will begin in 2011.
Dan Soland, chief operating officer of ViroPharma, said: “The filing of our PAS for industrial scale manufacturing takes us one step closer toward making product at enhanced capacity available to many more patients with HAE. We now have increased confidence in our goal of gaining approval for this scale up initiative for Cinryze this year.
“Our primary focus since the launch of this important drug has been on ensuring supply to all patients who choose prophylaxis against their attacks of hereditary angioedema, rather than to treat their dangerous attacks when they occur. Thanks to our current parallel chromatography scale manufacturing process, we are already doing so for even more patients suffering from the debilitating manifestations of HAE.”