Ben Venue extends plant shutdown
pharmafile | January 3, 2012 | News story | Manufacturing and Production |Â Â Ben VenueÂ
Troubled contract manufacturing organisation Ben Venue Laboratories has said it will have to extend its temporary shutdown of a facility in the US because it will take longer than expected to bring it up to code.
The announcement looks set to exacerbate shortages of Doxil (doxorubicin) a cancer drug made at the plant and sold by Johnson & Johnson, with the pharma company now saying it does not expect to resume supplies of the product made at the Ben Venue facility in Bedford, Ohio, until late 2012.
The CMO suspended production at the plant last November in the wake of “an internal review indicated that routine preventive maintenance and requalification of some manufacturing equipment was overdue,” according to a Ben Venue statement.
A later regulatory inspection uncovered additional quality problems at the unit, including concerns about the sterility of product made there and the potential for batch contamination.
Later that month, the European Medicines Agency (EMA) ordered a recall of various cancer drugs made at Bedford, such as Pierre Fabre’s Busilvex (busulfan), Millennium Pharmaceuticals’ Velcade (bortezomib) and Celgene’s Vidaza (azacitidine).
The company has already said it intends to phase out its CMO operations in the coming years, although this will have to be undertaken gradually as it is currently the only manufacturer of Doxil and also produces a number of other injectable cancer drugs that are in short supply.
Ben Venue said towards the end of last month that it “continues to conduct a site-wide assessment in order to fully understand the potential impact and implement any appropriate corrective actions that may be needed as quickly as possible to ensure that healthcare providers and patients have access to the medicines they need.”
The company says that a substantial amount of time and money will have to spent to bring the facility back into compliance, with at least one line expected to resume production in the first quarter of 2012.
However, one portion of the plant – known as the North facility – requires a major overhaul including reconstruction work that will require several months to complete. No products currently made at that unit will be available before the end of the year.
Phil Taylor
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