GSK has just entered into a two-year collaboration with the Technical Research Centre of Finland (VTT) to enhance quality control for drugs by using Process Analytical Technologies (PAT). The goal of the PAT is to develop drug process' production analysis into real-time quality control and to decrease significantly production costs.
The project aims to adapt optical instrumentation developed mainly for other process industries such as pulp/paper and metal to pharmaceutical processes.
Specific details of the technologies under investigation have not been disclosed, although the VTT has been working to develop measurement systems based on Raman spectroscopy for pharmaceutical applications. Raman spectroscopy has attracted considerable interest as a tool for PAT because of its ability to identify individual constituents in complex mixtures.
The project - worth up to €1.5 million to the VTT - will see measurement systems tested in several production lines including GSK plants in the UK, Italy, Spain and Canada.
"VTT's optical measurement methods, in drug production, will help pharmaceutical companies increase the quality and safety of their products" said the Centre in a statement. "Manufacturing cost of drugs play an important role in the cost of pharmaceutical products, as 40 per cent of the price is coming from production."
One of the major problems in developing drug manufacturing processes is the lack of fast and reliable measurement techniques. At the moment, the quality measurement technique consists mainly of slow laboratory analyses, which do not enable real-time quality control. The effective manufacturing of a drug takes only one to two days whereas in practice the whole manufacturing process may take as long as 30-60 days.
Just under a year ago, the US Food and Drug Administration published its long-awaited initiative on PAT, setting out a framework for companies to start exploring its use in drug production.
This initiative aims to allow drug companies to monitor their manufacturing processes continuously and automatically in real time, rather than intermittently and historically via samples and post-manufacturing quality controls. The result should be higher quality, reduced production costs and less wastage during manufacturing, according to the FDA.