At the end of 2013, Boehringer Ingelheim closed the doors at its beleaguered CMO Ben Venue Laboratories in Bedford, Ohio after years of quality and manufacturing issues – resulting in a number of major drug shortages - made remediating the sterile manufacturing site an unviable option.
Ben Venue was picked up for $85m as an option in 2014 when Hikma bought specialty pharma firm Beford Labs, though the firm said it had no plans to reactivate it, and today Xellia Pharmaceuticals has announced it is set to give the site – which is one of the largest sterile manufacturing sites in the world – a new lease of life.
“We have purchased around two-thirds of the site which equates to approx. 23 acres and includes four manufacturing units for sterile injectables,” Carl-Aake Carlsson, CEO of the Danish pharma firm, told this publication. Financial terms were not disclosed.
“The four units are all designed for the manufacture of sterile injectables but are of a different state and age,” he continued, adding “Xellia only plans to recommence operations in the new manufacturing units” which are more modern and built after 2000.
Considered, stepped start-up
The firm hopes to begin commercial production of its sterile injectable anti-infectives there within 24 months though Carlsson told us it will be “a significant task” requiring additional investment.
“The start-up of the facility will take place in a considered, stepped manner, using the new, modern units. We will not refit the entire site at this stage but will do what is needed to meet the compliance requirements.”
Hikma transferred a large number of modern, high quality machines - including lyophlizers and filling lines - to its manufacturing facilities in Portugal, Germany and the US following its acquisition, he continued, and so Xellia “will invest in new machinery” at the production site.
Furthermore, Carlsson said the firm would be working closely with the FDA to bring the site back online, and was well aware of the challenges faced by the site’s previous owners.
“Our operations at the site will be different compared to Ben Venue and we will manufacture different products. The site will be run according to the Xellia quota system, and we will invest both in the new facility and a new organisation with high quality management.”
Approximately 170 staff will be employed in functions including manufacturing, supply chain, distribution, quality, engineering, HR and finance over the next two years.