The firm has been fighting to get operations at its aseptic filling plant in Massachusetts, US, fully operational again following a multitude of regulatory hold-ups since it first took the plant over from Hyaluron in 2010.
Problems included an FDA (US Food and Drug Administration) warning letter in 2010 over cGMP (current good manufacturing practice), amongst other publically aired concerns from the organisation. Equities analyst for Jeffries & Co, David Windley, last year described the facility as a “money pit”.
But though critics were sceptical about the facility winning back lost clients , D’Ambra insisted that business is now on the up, and that the plant has finally seen an “improvement.”
Recent wins include a contract for sterile pre-filled syringes with Cardium Therapeutics and its subsidiary, Tissue Repair Company, and company leaders say more are in the pipeline.
During the Q2 conference call, D’Ambra added that the Burlington team are also in discussions over “an important oncology drug” set to hit the market soon.
Large scale biz unbothered
As for AMRI’S services business, large scale manufacturing was the only section to see an uptick in business in Q2, hitting $25.7m as opposed to $25.5m in the same quarter last year.
Small scale manufacturing was the worst hit with an 11 per cent dip from $9.1m in 2011 to $8.1m, whilst discovery services saw a more gentle decline down three per cent from $8.9m to $8.6m.
The results follow the closure of AMRI’s chemistry services facility in Hungary this year – now relocated to Hyderabad in India – which provided custom synthesis and discovery support services.
In March, when the facility was axed, a shift in the biopharmaceutical sector was blamed .