More Manufacturing Issues Lead to Alexion Recall

By Dan Stanton contact

- Last updated on GMT

More Manufacturing Issues Lead to Alexion Recall
Alexion Pharma International has recalled a single lot of its monoclonal antibody (MAb) orphan drug Soliris due to the presence of visible particles in a limited number of vials.

The recall was documented in a filing with the SEC​, where the firm said “the particles were recently observed by Alexion as part of its routine testing” ​at the facility of a contract manufacturer used to make the drug.

However, the firm – a subsidiary of Alexion Pharmaceuticals - remained confident that the supply of Soliris will not be affected with a second third party manufacturing facility being employed to ensure constant supply.

Furthermore, Alexion has announced it is initiating a deal to contract the filling, packaging, and labeling of the drug to a third CMO (contract manufacturing organization), expected to be finalized later this year, with a fourth contract vialer expected in 2014.

Alexion also manufactures Soliris at its own facility in Rhode Island, US, which was hit by a warning letter​ earlier this year from the US Food and Drug Administration (FDA), following the discovery of microbial contaminants.

Soliris (eculizumab) is Alexion’s MAb orphan drug for treatment of rare blood and kidney disorders and, according to The Independent​, costs more than £300,000 ($470,000) per patient per year.

Dan Rosenblum, a biotech expert at Sharkinvesting, wrote on Twitter yesterday: “Soliris costs 300x per oz more than gold, one would think Alexion would be able to deal with manufacturing issues.”

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