Ben Venue Laboratories will not restart manufacturing at its Bedford, Ohio, US facility until later in the first quarter after extending the voluntary suspension it implemented in November 2011.
The US contract manufacturer initially suspended production at the plant after inspections by the US FDA, EMA, and other global regulatory agencies voiced concerns about quality management.
EMA’s Committee for Medicinal Products for Human Use (CHMP) subsequently recalled bone marrow cancer drugs Busilvex and Velcade, which are produced in Ohio, as a precaution.
The firm said on 23 December that it would continue to conduct a site-wide assessment and implement any appropriate corrective actions as quickly as possible.
Ben Venue said it can no longer continue to manufacture and remediate simultaneously and must direct its focus on addressing manufacturing-related issues.
The Bedford operation is one of the largest sterile injectable facilities in the world, with aseptic filling, lyophilisation and cytotoxic manufacturing in four factories.
The firm added that due to the distinct technologies and manufacturing processes in each factory, issues are being addressed separately. The firm will then resume production one line at a time.
‘We are now working to restore some manufacturing in the first quarter of 2012, and will provide updates as they become available,’ the firm said.
Ben Venue said a ‘substantial investment of time and resources’ would be required to make necessary improvements in the firm’s North facility, where several sterile injectable drugs currently in short supply are manufactured. The facility requires ‘major reconstruction’ that may take up to nine months to complete. Ben Venue anticipates that no products manufactured in this facility will be available before the fourth quarter.
‘Our highest priority is to resume manufacturing and delivery of safe and effective products, and we are committed to working as quickly as possible to resolve the issues that have affected production,’ the firm said.