AMRI wins new contract for rehabilitated facility
pharmafile | June 6, 2012 | News story | Manufacturing and Production |Â Â AMRI, Carduium Therapeutics, FDA, TaylorÂ
Albany Molecular Research Inc (AMRI) has won a contract to fill a newly-approved product into sterile syringes at its facility in Burlington facility in Massachusetts, US, which has just emerged from a lengthy remediation programme after an FDA warning letter.
The contract has been awarded by fellow US firm Cardium Therapeutics, which will use Burlington to fill its recently-launched Excellagen wound-healing product. The formulated collagen product was launched in the US in April for treating diabetic foot ulcers, pressure ulcers and other dermal wounds.
AMRI said earlier this year that it had got the Burlington plant back on track after a 2010 FDA inspection revealed a number of Good Manufacturing Practice (GMP) deviations, including particulate matter contamination in finished products and a failure to follow written procedures designed to prevent microbiological contamination of drug products.
The issues date from the time the Burlington facility was owned by Hyaluron, which was acquired by AMRI in the same year as part of a drive to build its capacity in the filling and finishing of injectable biopharmaceuticals, which has been showing double-digit growth in recent years.
Burlington provides formulation and filling services for pre-clinical through small-volume, commercial-scale production of liquid-filled parenterals, biologics and medical devices in vials, syringes and other custom containers.
In April, AMRI said the FDA had given a preliminary green light to its remediation efforts at Burlington. The company has continued to beef up the quality operations at the site, recently hiring Thomas McGrath as its new director of quality for aseptic services, Stephen Rossmeisl as senior facilities manager, and Chris Phillips as senior director of operations.
AMRI’s most recent financial guidance indicates it hopes to bring in contract revenues of between $176 million and $186 million in 2012, which would be an increase of around 10% over 2011, and return to profitability. The company expects one of the drivers of that growth will be continued improvement of clinical/large-scale manufacturing services revenue at Burlington.
The company recently announced a restructuring exercise to boost profitability, centred on the closure of a facility in Budapest, Hungary, and downsizing of the workforce at a plant in the US.
Phil Taylor
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