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Materials efficiency

Improving the efficiency with which we convert raw materials to finished product is an important objective for environmental sustainability. It will help us to reduce our consumption of natural resources, waste generation and the cost of production. We believe we will be able to double material efficiency by 2010 for new processes coming out of R&D Chemical Development, achieving material efficiencies for active pharmaceutical ingredient of 2% (ie two tonnes of active pharmaceutical ingredient for every 100 tonnes of input chemicals) for these new processes. We will propose this as a target for the new five-year plan.

Our efforts are supported by the US drug regulator, the Food and Drug Administration (FDA). The FDA is now focussing on process technologies and recommends that pharmaceutical manufacturers increase their focus on manufacturing processes.

The pharmaceutical industry has tended to use much more raw material for every kilo of finished product than other process sectors such as the agrochemicals and fine chemicals industries. Pharmaceutical processes are typically very complex, usually involving many separate operations and often requiring relatively large amounts of solvent. Typically, the industry uses about 100 kg of material for every kilogram of active pharmaceutical ingredient produced. That 1% material efficiency compares to about 20% for fine chemicals and 50% for bulk chemicals. It represents a waste of valuable resources, with financial as well as environmental consequences, and GSK aims to make improvements in the future.

Our approach to addressing EHS issues already includes minimising the amount of material used. The FLASC green chemistry tool includes the mass of material used as part of the lifecycle assessment of material impacts. But Chemical Development scientists have other targets, especially quality issues and minimising the timescale for developing the manufacturing process, which may conflict with improved material efficiency.

We have begun placing a higher priority on improving our use of materials and are bringing together R&D and manufacturing teams to increase the focus on material efficiency in the product development stage, as well as for selected existing products. We use two key measures of production efficiency:

• Mass productivity – the mass of all materials used in the process compared to the mass of product produced
• Reaction Mass Efficiency (RME), which gives a measure of the efficiency of putting together the key building blocks of a drug molecule – excluding the large volumes of solvents which are normally used as a medium for the chemical reactions, and other materials which are essential to the reaction or process

We are already making dramatic improvements to materials efficiency. For example, the R&D team at Tonbridge, UK, increased production mass efficiency to 2.7% in the production of an anti-retroviral drug. The chart shows substantial efficiency improvements during the development phase of several new compounds during 2005. These examples demonstrate the potential for improvement, although this scale of improvement cannot be achieved in all processes. We aim to build on such successes in R&D and manufacturing. The EHS Plan for Excellence will include an improvement target for material efficiency for products emerging from R&D.

 

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