Pharmaceuticals
Introduction
Pharmaceuticals are one of Britain’s leading manufacturing sectors with a turnover of £13.7 billion and a trade surplus of £4.3 billion in 2006. The industry has grown rapidly over the last thirty years built on an impressive track record of new drug development. Nearly 20 per cent of the world's top medicines were discovered and developed in Britain. On average, it takes around 10 to 12 years and £550 million to develop a new medicine, with no guarantee that a medicine will go on to be a commercial success. Given the nature of the products the industry is highly regulated by the U.S. Food and Drug Administration (FDA).
The industry is now facing a number of challenges and opportunities:
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The rate of successful new drug launches is decreasing
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Generic competition from low wage economies when drugs loose patent protection
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World wide governmental pressure to reduce the costs of drugs which represent both a significant % of the health budgets and in some countries are too expensive for the local population.
These pressures are resulting in a greater emphasis on Operational Excellence and a growing move from the traditional batch to more continuous manufacturing process. A key element of this process is the need for rapid on line process analytical technology (PAT) to accurately measure the drug properties at the point of manufacture. To install such technology it must satisfy the regulatory authorities in the form of CFR11.
Solution
Process tomography provides a useful tool to the pharmaceutical sector and ITS has the appropriate management systems and software to provide CFR11 approved instrumentation.
It is able to help characterise complex processes such as crystallisation. As well as determining concentration variations through a vessel, ITS supplies ultrasound spectroscopy instrumentation which can provide particle characterisation information.
ITS is also able to provide information on key unit processes such as mixing, filtration and liquid-liquid separation. This offers the benefit of reducing batch cycle times and improving batch to batch consistency.
