Lonza to set up dedicated manufacturing suite for Alexion
The Swiss life science services firm said it will set construct the dedicated suite at its facility in Portsmouth, New Hampshire, explaining that it will supplement manufacture of Alexion products made under an existing contract.
According to Lonza it will enable “Alexion to add dedicated product supply for 10 years,” although no specifc products were named.
In March, the US Food and Drug Administration FDA) granted Alexion's candidates drug asfotase alfa, an enzyme replacement therapy for patients with infantile- and juvenile-onset hypophosphatasia (HPP), priority review status.
However, at present Alexion's only approved product is Soliris (eculizumab), a monoclonal antibody treatment for the rare disorders paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome (aHUS), which Lonza has made on the firm’s behalf for almost a decade.
Whether this extra capacity will prompt Alexion to reduce what it charges for Soliris- £327,600 ($511,512) a year according to NICE – remains to be seen. However, the firm did cite manufacturing as part of the reason for its cost during a review in 2014.
Alexion declined to comment when contacted by BioPharma-reporter.com.
CMO strategy
The decision to dedicate capacity to Alexion does not mean Lonza will abandon its multipurpose facilities.
COO Mark Funk said: “Our new offering of suites with dedicated manufacturing capacity will give customers greater flexibility in determining production quantities and timings.
“At the same time, we’ll continue to offer our services in our multi-purpose plants to meet our customers’ needs” he added.
