The contract manufacturing arm of Boehringer Ingelheim says it cannot return to sustainable production
Ben Venue Laboratories, of Bedford, Ohio, the US contract manufacturing division of Boehringer Ingelheim, will stop production by the end of the year, following a number of manufacturing violations found by US Food and Drug Administration (FDA) inspections.
The firm said that in spite of the support of the FDA, its employees and investment in facility upgrades, it cannot return to sustainable production.
Although Ben Venue implemented interim controls to assure product quality, which have been effective to date, in the long term, they are not sustainable, the firm said.
\'The magnitude of continued investment and time required to overcome the systemic manufacturing challenges is not viable,\' the firm said.
Given the age and condition of some of its facilities, combined with the findings from its third-party current Good Manufacturing Practice (cGMP) experts and ongoing remediation needs, Ben Venue projects that in addition to the more than US$350m invested to date, there will be significant additional cumulative operating losses of approximately $700m over the next five years.
The closure will affect all of Ben Venue’s workforce of approximately 1,100 over a phased reduction starting this month (October) and continuing into 2014 as the company winds down.
The magnitude of continued investment and time required to overcome the systemic manufacturing challenges is not viable
Ben Venue said Boehringer Ingelheim is exploring strategic options to continue the supply generic sterile injectable products.
In June, Ben Venue said it would concentrate production in its newer, more commercially sustainable facilities and cease production in one of its older manufacturing facilities and end aseptic filling operations in its oldest manufacturing facility by the end of the year. The firm said this new organisational focus would allow it to continue to employ around 800 people in its manufacturing operations.
In January, the firm voluntarily entered into a consent decree with the FDA, under which it was allowed to continue to manufacture and distribute more than 100 drugs. The firm was also permitted to continue drug-development activities, and file abbreviated new drug applications (ANDAs).
Ben Venue had invested more than $300m to upgrade its facilities up to January 2013, making necessary improvements and changes to processes to address the manufacturing issues revealed during an FDA inspection in May 2011, which resulted in its decision voluntarily to halt manufacturing in November 2011.
By October 2012 the firm said it had resumed production on a limited number of manufacturing lines at Bedford and anticipated that production would resume on additional lines as corrective measures to address facility and equipment issues were implemented.
Ben Venue\'s operation in Bedford is one of the largest sterile injectable facilities in the world, with aseptic filling, lyophilisation and cytotoxic manufacturing in four factories.