Incorporating a refined version of an existing technology into the development of new biopharmaceuticals will enable UK companies to compete effectively in a multi-billion dollar global market.

The need
As the medical profession searches for new ways to fight disease and illness, the American Food and Drug Administration has led an initiative to get better biopharmaceutical products onto the market quicker. PAT – Process Analytical Technologies – applies existing technology systems in a novel, cutting edge way in the production process of new biopharmaceuticals. It reduces development time and produces a product of significantly higher quality, benefiting both the industry and the consumer.

It’s likely that, in the future, no regulatory bodies will license new biopharmaceuticals which do not incorporate these technologies.

And to put this into a financial context: the world-wide market for one biopharmaceutical, IgG, is expected to reach $26bn by 2010. The global pharmaceuticals market is poised to grow at a CAGR of 11.6% from $64.5bn in 2007 to $135bn by 2014 (Frost & Sullivan, 2007).

The results
The £2.5m three-year project introduces Near Infra-Red Spectroscopy - a technology previously used for assessing the quality of raw materials and finished products - into the early stages of developing a new biopharmaceutical. It’s at the development stages many products fail – only one in 12 will make it to market, and of that number, one in three will show a profit for the company.

Previous monitoring of bioprocesses has relied on more traditional methods of analysing samples which might take hours or even up to a day, by which time the process has moved on. Using biosensors and Near Infra-Red Spectroscopy, it’s now possible to get a real-time evaluation of what is happening in the bioreactor. Control and monitoring of the process is much closer and more effective, and multivariate analysis of the data enables predictive modelling.

The advantages

• more efficient control of the process means that products that won’t make it to market can be identified earlier, saving production time and costs
• deviations in the process can be spotted and corrective adjustments made
• there have been some severe allergic responses from individuals to biopharmaceuticals; improved processes will mean purer, better products

Innovation Results : Biopharmaceuticals: Meeting the challenge of change

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