Breaking News on Global Pharmaceutical Technology & Manufacturing

Alexion’s Solaris site given positive opinion

By Staff reporter, 07-Dec-2009

Related topics: Contract services (outsourcing), QA/QC, Ingredients

Alexion Pharmaceuticals’ manufacturing facility in Rhode Island, US has received a positive opinion from the CHMP, furthering its efforts to gain in-house capacity to supplement a deal with Lonza.

The facility was acquired from Dow in 2006 and since then Alexion has worked to equip the site for production of Soliris (eculizumab), a treatment for rare blood disorder paroxysmal nocturnal hemoglobinuria.

Alexion is now nearing the end of this process and has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

The CHMP’s positive opinion recommends the European Commission approves the site, which is expected to occur in early 2010. Gaining approval would allow Alexion to use the Rhode Island site as a second source for supplying the European Union.

To date demand for Solaris has been met through a supply contract with Lonza but Alexion has stated it wants to source the drug from multiple sites, one of which will be its Rhode Island facility if approval is gained.

As part of this effort Alexion is planning to meet the US Food and Drug Administration (FDA) to provide additional information and discuss the agency’s request for a limited number of production runs in connection with the pre-approval inspection process.

External vialer

Alexion has also provided an update on a regulatory review of an external vialer previously used by the company. The authorities have permitted release of the batches of Solaris filled by the vialer, resolving the issue at no loss to Alexion.

Copyright - Unless otherwise stated all contents of this web site are © 2012 - William Reed Business Media SAS - All Rights Reserved - For permission to reproduce any contents of this web site, please email our Syndication department copyright@wrbm.com - Full details for the use of materials on this site can be found in the Terms & Conditions

© 2012 - William Reed Business Media SAS - All rights reserved.