The manufacture of Active Pharmaceutical Ingredients (APIs) in the UK has undergone a radical transformation compared with 30 years ago. Back then, this vitally-important industry was dominated by a more traditional approach to manufacturing, in a very modest range of technology. Now production is very different, to the extent that we talk of being part of a revolution, with more efficient, more modern manufacture, and a much better use of resources. This is not just a response to the market but a move towards a more sustainable, high-tech future.
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One legacy of its days as a pharma powerhouse is a cluster of world-class technical companies who have supplied the sector for years. Facing fierce global competition, however, there is an increasing demand to change with the times. One element of this is making the UK more attractive for high-tech operators through enhancing their competence in complex chemistry, biotechnology and advanced manufacturing techniques, such as continuous manufacturing and modular production systems. Against this backdrop, the stage looks set for the UK to make a considerable impact in the global production of APIs.
It represents nothing less than an evolution in the very culture of the industry. The collaborative atmosphere between academia and industry is fuelling rapid commercial development, bringing cutting-edge science to bear upon the opportunities for providing manufacturing services within the UK.
Additionally, the regulatory environment has undergone changes, with agencies such as the Medicines and Healthcare products Regulatory Agency (MHRA) having a critical role in ensuring that innovation in manufacturing processes can accommodate rigorous standards for safety and quality. This has resulted in a brighter future that supports both innovation and enhanced consumer and stakeholder confidence. The UK’s dedication to high regulatory standards along with its support of innovation is proof that both can be achieved with the right infrastructure, skilled professionals and public health in mind.
Alongside regulatory improvements, growing sustainability awareness within the API manufacturing sector is readily moulding the direction of change, with many companies looking for ways to reduce their environmental footprint, whether it be through more sustainable manufacturing processes or the use of renewable resources – the need for which will only increase due to growing consumer demand for ethical and nature-friendly pharmaceuticals. The UK leads in this area and it will be an interesting example for other nations to follow. The lesson of innovation and its sustainability is learnt through questioning, examining value systems, and never giving up.