Interim controls implemented to assure product quality were deemed no longer sustainable by the Boehringer Ingelheim subsidiary Ben Venue Laboratories earlier this month, and the contract manufacturer has been earmarked to close permanently by the end of the year.
1,150 jobs are set to go but “options about what to do with the site and buildings are being evaluated,” spokesperson Marjorie Moeling told Outsourcing-Pharma.com.
The site has been running since 1941, Moeling told us, growing throughout the 1960s, 70s and 80s to meet business requirements and demand. The company was acquired in 1997 by Boehringer Ingelheim who expanded its production capacity with the addition of the Phase IV facility, including lyophilization and sterile liquid filling capacity.
However, various violations of GMP over the last few years have haunted Ben Venue, leading to recalls and limited manufacturing capacity. Earlier this year the company received a consent decree from the US Food and Drug Administration (FDA).
The facility - some of which has been described as aged and of a poor condition by the company itself - has seen over $350m (€256m) invested in remediation efforts of late. Whilst Ben Venue’s plans for the site are still undecided, property website City-data.com estimates the marked value of the buildings at almost $64m, based on 2008 tax records, with the land itself worth $530,000.
Repercussions of past manufacturing shutdowns have been felt in the form of drug shortages, but regulatory bodies are more prepared with the announced permanent closure. The EMA’s Committee for Medicinal Products (CHMP), for example, is discussing the closure of Ben Venue in meetings this week.
“The EMA is aware that Boehringer Ingelheim is to close its manufacturing site,” said a statement sent from the Agency to Outsourcing-Pharma.com, “due to the investment needed to overcome the shortcomings in the manufacturing facility and quality assurance systems.”
Of the fourteen drugs made by the company for the European market, the agency took action to remove Ben Venue Laboratories as an authorised manufacturer for eleven, with replacement manufacturers being sourced. Two more (Luminity and Vibativ) have had their marketing authorisations in the EU suspended.
However, for Janssen’s chemotherapy drug Caelyx (known as Doxil in the US), though a second manufacturer has been sourced, the alternative site “does not have the capacity to meet demand in the EU and the marketing authorisation holder is working on measures to try to prevent a shortage.”
Any actions “to mitigate the effects of a shortage of Caelyx” would be discussed during the meetings, the Agency said, with outcomes to be announced forthwith.