Almac Provides Urgent Packaging Services

Almac provided rapid packaging and distribution of Alexion Pharmaceuticals’ Soliris during an E. coli outbreak in Germany this past spring and summer. The large outbreak of food-borne E. coli infection resulted in more than 800 cases of STEC-HUS (Shiga-toxin producing E. coli hemolytic uremic syndrome), an ultra-rare and life-threatening complication of the infection.

Alexion contracted Almac for assistance in delivering the drug, packaged and labeled, to the EU, and requested an extremely short turnaround time to distribute the drug product. Soliris is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare and life-threatening blood disorder, and atypical hemolytic uremic syndrome (aHUS), a debilitating and life-threatening genetic disorder. German physicians were using Soliris in STEC-HUS on an investigational basis. The study evaluating the safety and efficacy of Soliris for the treatment of STEC-HUS is ongoing.
 
“Almac understood the importance of meeting this critical timeline to Alexion and ultimately the German patients.  Because of this, the project had visibility to the highest levels at Almac and meetings were held daily to ensure that nothing was missed or allowed to cause delay,” said Donna Christopher, vice president of operations at Almac’s Durham, NC facility. “This was a very gratifying collaboration for Almac to be involved in, as we were able to make an immediate impact to a highly publicized public health crisis.  This was satisfying to everyone who worked on this project.”
 
Almac processed (within 48 hours) the current commercial Soliris drug product stock held at Craigavon, UK on a named patient basis to treat this life threatening condition. When the initial urgent requirement was met, Almac was then able to scale up the packaging and distribution of the clinical trial product.