The UK’s life sciences and pharmaceutical sector is renowned for being world class. Many talented scientists from other countries have come here to research and develop drugs and innovative technologies, and great breakthroughs in this field – from Sir Alexander Fleming’s discovery of penicillin to the discovery of the structure of DNA and antibody therapies – have happened in the UK.
The UK life sciences industry sustains high-value jobs. However, post-Brexit, scientists are worried that outside the EU they will find it harder to recruit the best researchers to the UK and will be cut off from lucrative European research grants and collaborations. The European Medicines Agency, based in London, is also contemplating relocating to one of the remaining EU member countries.
But Brexit is not the only concern. There are more fundamental issues to consider if the UK is to continue to lead the world in medical science. The country’s industry needs to show a willingness to invest in innovation, increasing the use of automation and embracing the digital revolution, throughout the factory.
With expiring patents, rising costs and a competitive marketplace, life sciences and pharmaceutical manufacturers are under pressure. Alwyn Jones, head of pharmaceutical and life sciences at Siemens, says: “The sector is undergoing some rapid changes. Gone are the days when all the big companies are trying to chase the next blockbuster multi-billion pound drug and bring that to market as quickly as possible to make the big bucks.
“These days they know that those kind of products are not going to be the future. The sector is facing significant challenges. We are becoming more demanding.”
There is also a rising need for personalised medicine – patients are demanding customised treatments with better results and fewer side effects. To remain competitive, manufacturers will need to speed up their product release cycle while meeting demands to manufacture personalised medicine. Investing in innovation is key.
Jones says: “What pharmaceutical companies make needs to be produced in a cost-effective way. When you’re changing from what used to be large-scale, mass-volume batch production to a small-scale, personalised drug or small batches, you can’t use the same technology. You’ve got to invest in new technology, such as continuous manufacturing.”
There is a shift from batch processing to a more continuous approach to manufacturing taking place. Continuous manufacturing allows for an uninterrupted flow in the process, from putting together the starting materials to creating the final product. By getting rid of individual batches, higher-quality drugs can be created for less cost.
Novasep, a supplier of technologies for the life sciences industry, launched its BioSC Lab, low-pressure chromatography equipment, which is used to separate components of mixtures, in 2015. With BioSC Lab, scientists can purify a few grams of proteins per day either in continuous, batch or parallel batch modes. And the company’s simulation software BioSC Predict frees the process developer to set the most efficient mode and parameters to purify biomolecules such as monoclonal antibodies, blood factors and other proteins.
Jean-Luc Beulay, product development director of Novasep’s biopharma business unit, says: “Manufacturers are optimising their processes, and producing more and faster. They are looking for new tools that will help them go in that direction. That’s the reason why we decided to launch the BioSC Lab, which helps customers move from batch to continuous processing in an easy manner.”
The technology also takes up less space – in some cases just a tenth of what is needed for batch process equipment.
However, moving from batch to continuous processing does mean a major overhaul in infrastructure and a high initial investment. Jones says: “There are still many companies using traditional batch manufacturing, but the margins are on the decline. To remain competitive they need to invest in new technology, but some companies are reluctant.
“They are trying to make the most out of the equipment that they have on site rather than invest in new equipment and automation. This can bring about a lot of risks because old equipment can be prone to failure, and can be damaging to the company if you perhaps lose a batch, or have some unplanned downtime.”
The pharmaceutical industry generally has been hesitant to introduce innovative systems into manufacturing. One reason often cited is regulatory uncertainty. “Other sectors such as automotive and aerospace have been embracing automation and innovation for many years,” says Jones. “For the pharma sector manufacturers to remain competitive, they have no choice but to move towards the digital enterprise and embrace digitisation.”
The caution in applying digital technology to improve manufacturing and supply chain operations is becoming a hindrance as the industry moves towards personalised medicine. By applying digital technology, companies can increase visibility of their supply chain operations and make better and faster decisions.
Digitisation allows companies to fully integrate their supply chains and improve operational processes, making them more adaptive and responsive. Planning accuracy, productivity, inventory levels, and service levels can improve.
Jones says: “Industry 4.0, or the fourth industrial revolution as some people refer to it, has helped companies improve their productivity and enable a flexible approach in manufacturing across the board. Digitisation can help across all of the steps of the product lifecycle, and our value proposition at Siemens is focused on an integrated data landscape from engineering through to operations. We are already helping many companies shape their pharma factories of the future.”
Last year, pharmaceutical company GlaxoSmithKline (GSK) opened its first research and development facility designed to test new technology, with a focus on realtime electronic data visualisation.
The idea behind the Immersive Intelligent Manufacturing lab is to show the opportunities presented by automation, manufacturing execution systems, analytics, and informatics in pharmaceutical manufacturing.
The lab, in Stevenage, Hertfordshire, is a production unit for a continuous oral solid-dosage drug manufacturing line. The ‘smart space’ was designed by design firm PWW to demonstrate how state-of-the-art technologies can be combined in a manufacturing line and environment. The facility is set within a 700m2 industrial space.
“GSK have invested heavily to look at innovation in many areas of pharmaceutical manufacturing,” says Jones. “They are using this facility to change the way they go about producing and developing products, from the lab all the way through to packaged products, and everything in between – how they operate and optimise their production facilities. So within this facility they use a whole host of technologies from Siemens and many other technology vendors.
“They do a lot of intelligent things with the data that’s generated along the entire product lifecycle and they use this data in a meaningful way to improve the processes in real time and after the event as well.”
GSK is harnessing Siemens’ process control with Simatic PCS 7, a control system that Siemens explains responds quickly to constantly changing market requirements through its user-friendliness, high system availability, investment security, and future-safe technology. GSK is also running performance analysis with XHQ, which enables decisions based on realtime performance management; production scheduling with Preactor; and electronic batch records created and managed with Simatic IT eBR.
The project team rapidly designed and built the Immersive Intelligent Manufacturing facility, and it is now being used to accelerate technology adoption within GSK. “The team is very busy refining solutions that can be deployed in a real manufacturing process and they’re taking the good work they’ve done to help shape new capital investment projects,” says Jones.
Without embracing innovation, pharma and life sciences companies could quite quickly find themselves falling behind. Digitising the supply chain can help companies significantly improve their performance and ultimately strengthen their financial outlook.