The voluntary recall covers nine lots of the drug distributed in the US last October in which visible proteinaceous particles were detected during stability testing.
Alexion said it does not anticipate any shortages of Soliris (eculizumab) which is an orphan monoclonal antibody drug for the treatment of rare blood and kidney disorders.
“Following this voluntary recall, there will no longer be Soliris in the US manufactured using the previously identified process component that Alexion believes resulted in the stability failure,” the firm said in a statement.
According to Alexion's 2013 annual report Soliris is made at a plant the firm operates in Rhode Island and also at two other facilities by its CMO Lonza. The firm did not disclose at which facility the lots recalled were produced and did not respond to requests for further information.
Manufacturing
The news comes as the latest in a number of manufacturing problems the firm has had, with a recall last August of a single lot of Soliris made by its contract manufacturer once again due to the presence of particles in a limited number of vials. A recall of a further two lots was voluntarily initiated in November.
In March last year, Alexion’s own and only Soliris manufacturing plant in Rhode Island was hit by a US Food and Drug Administrator (FDA) Warning Letter, after several lots of the drug were found to be contaminated with the bacteria Bacillus thuringiensis and the microorganism, Acinetobacter radioresistens.
Evaluating its Network
Biopharma-Reporter.com visited Alexion’s Irish headquarters in Dublin last month, and spoke with General Manager and SVP of Global Manufacturing Operations, Julie O’Neill about the firm’s manufacturing and quality strategy.
At present the firm is evaluating its entire production network, she said, as well as investing considerably in-house to support Soliris and its pipeline. In Ireland a facility in Blanchardstown, Dublin is currently under construction, whilst the firm also bought a vialling plant in Athlone, County Roscommon earlier this year.
“At Alexion we are at a stage where our network is evolving, and we look at capacity based on a number of prerequisites,” she said.
“Compliance is the rule of the game from any manufacturer’s perspective and that’s the first area of focus for any company in site selection. Alexion is at an early stage in its lifespan having commercialised products and as we grow we will look at all alternatives but it will be to a very predefined set of criteria and hopefully we will find partners who will meet that criteria.”