Almac automates pre-trial validation with HP’s help
The Northern Irish contract development group used HP’s Quality Centre platform to create an automated IT infrastructure for the testing and analysis of procedures needed to manufacture drugs being examined in clinical trials.
Regulators like the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) require that such validation and compliance work is completed before trials can begin.
In a press statement Almac Group chair Sir Allen McClay suggested that use of the software platform to streamline the necessary validation and compliance steps needed for approval may have wider benefits for the drug sector.
“By using HP technology we help speed the move from innovation to clinical practice, resulting in significant market advantage and enhanced competitiveness for our customers across the world.”
Martin Murphy, managing director of HP in Northern Ireland, said that his firm is “helping Almac shorten the validation aspects of its software development while at the same time ensuring that it can meet manufacturing best practices globally.”
Almac, which was named business of the year at the 2009 Belfast Telegraph Northern Ireland Business Awards earlier this month, showcased its new software setup at the recent global ICT summit held in Vienna, Austria.
With the average cost of drug development topping the $1.5bn (€1.1bn) mark and taking anywhere from five to ten years, pharmaceutical firms are keen that candidates move from the laboratory to the marketplace in the shortest time possible.
As a result companies like Almac that can shorten the trial process are likely to be in great demand, particularly in an era of blockbuster patent expiry and dwindling product pipelines.
The positive impact of Almac’s automated approach to validation on trial timelines would suggest that the firm will employ a similar system at its $78m clinical facility which is currently under construction in Pennsylvania, US.
