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The processes and chemicals used in drug production are often toxic, expensive and produce a lot of waste – posing a threat to the environment and the sustainability of the industry.
Currently, every 1 kg of active ingredient can take 100 kg of materials to produce, requiring huge facilities for production and waste disposal, and long lead times. The results are not only bad for the environment but extremely expensive. Such processes can also impact on the global competitiveness of the industry.
In response, the EU and industry-funded CHEM21 project has developed new manufacturing processes for the pharmaceuticals industry to reduce the use of expensive and toxic materials. It has also developed new more environmentally friendly methods that save time and costs, while reducing waste.
Nick Turner, the director of the UK’s Centre of Excellence for Biocatalysis, Biotransformations and Biocatalytic Manufacture (CoEBio3) says the project was diverse and complicated but has resulted in huge successes. CoEBio3 is involved in CHEM21 through its association with the University of Manchester – a project partner.
“Our flagship outcome is the development of a new, more efficient and cheaper way of producing flucytosine,” he says. “This medicine is used to treat a common and often deadly fungal form of meningitis in HIV/AIDS sufferers. Producing it at low cost will make it more accessible to those in Africa, helping in the prevention of 500 000 deaths per annum.”
CHEM21 was funded by the Innovative Medicines Initiative, a joint undertaking between the EU and the pharmaceutical industry.
A future with flow chemistry and biocatalysts
CHEM21 has advanced chemical engineering techniques to make flucytosine available to more people across the globe and, in the future, the same will be true for other drugs manufactured using these processes.
When this drug is made using new flow chemistry methods, expensive toxic chemicals are not needed, fewer raw materials are required and there is reduced wastage. This means costs are reduced and the process is cleaner and safer.
The project has also developed new, more efficient screening methods to find more enzymes that can be used as biocatalysts for chemical reactions. The discovery of new ones could make drug manufacturing processes more efficient and safer as they can eliminate production steps and could be substitutes for expensive or toxic substances currently used by the industry.
Open access training resources
The project has also developed educational and training resources relating to its work. These included the development of a Massive Open Online Course (MOOC) on industrial biotechnology. In addition, the company Bisy e.U used CHEM21 to develop new and faster cloning methods for producing biocatalysts that are proving attractive to the wider pharmaceutical industry.
The UK’s University of York, a project partner, developed educational materials that will contribute to training the process chemists of the future.
Turner concludes: “The development and launch of pharmaceuticals is a long process, so it is to be expected that many more benefits will become realised in the next 5-10 years.”