Reinspection lands Alexion with 483 for Soliris plant

25-Aug-2014 - Last updated on 12-Dec-2023 at 11:56 GMT

A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has resulted in a Form 483 with three observations.

The Smithfield, Rhode Island facility is owned and operated by Alexion as one of three plants that manufacture the human monoclonal antibody drug Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

In March 2013, the facility was hit by a US Food and Drug Administration (FDA) warning letter after six lots of the API for the drug were found to be contaminated with the bacteria Bacillus thuringiensis and the microorganism Acinetobacter radioresistens.

Since then the firm has issued several recalls of what - at approximately $600,000 per patient per year - is the world’s most expensive drug, but last month CEO Leonard Bell told investors during Alexion’s second quarter results the firm was awaiting a reinspection following “continued improvements” at the site.

However, according to a statement sent to Biopharma-Reporter.com by spokesman Irving Adler, the facility was reinspected by the FDA during the week of August 18, which issued a Form 483 with three inspectional observations, none of which were repeat observations from the original warning letter.

“The three observations include a need for enhanced training around gowning procedures, more frequent environmental monitoring, and processes related to identification of the definitive root cause of a prior bioburden excursion,” we were told.

“We continue to manufacture products, including Soliris, in Smithfield and other facilities,” he continued, “and we believe that the supply of Soliris to patients will not be interrupted.”

The two other facilities making Soliris are operated by Lonza in agreements that stretch until 2019.

We contacted the Switzerland-based contract manufacturing organisation (CMO) to ask if Soliris capacity has been increased on the back of Alexion’s manufacturing problems, but a spokesman told us the firm was “not in a position to comment,” on this or the process involved in making the MAb.

However, according to Alexion’s 2013 annual report, the “manufacture of Soliris is difficult” as it “requires a multi-step controlled process and even minor problems or deviations could result in defects or failures.”