The biopharmaceutical industry is one of the most complex and technologically challenging sectors, yet for all the billions of dollars invested into medicine manufacturing the techniques and technologies haven’t significantly changed in decades.
Until very recently, most medicines have been manufactured using traditional batch processes, with each operation taking place separately and consequentially. While other sectors have embraced continuous flow manufacturing or continuous processing, the biopharmaceutical sector has been slow on the uptake. This is partly due to concerns over perceived issues such as contamination risk or control challenges, partly due to the highly regulated nature of the sector, and also perhaps due to the familiarity of batch processing and the unwillingness of some manufacturers to venture into the unknown.
But the status quo isn’t good enough anymore. We are in an era of increasingly personalised, precision medicine, where the ability to expedite and industrialise the development of ‘drugs on demand’ could be truly transformational for patients worldwide. Now is the time for medicine manufacturers to seize the opportunity that continuous bioprocessing offers.
Most manufacturing sectors, from automotive to food to metal production, have already adopted continuous processes. The benefits that have been achieved in these industries has been remarkable. Increased efficacy, reduced capital costs, increased reliability, reduced failure rates, improved process control, and accelerated speed of bringing new products to market are just some of the improvements that continuous processes are driving.
The biopharmaceutical industry may be late to the party compared to other manufacturing sectors, but after a slow start we are now seeing things accelerate rapidly. Our customers are now moving away from batch production towards a more continuous culture. They are going through ‘process intensification’ steps at the moment, whereby clusters of unit operations are being bought together and compacted. And more and more, when they are coming to Pall, they are asking for us to develop an end-to-end continuous process for them.
Where we will really see continuous bioprocessing positively impact biopharmaceutical companies is by enabling them to explore new, complex medicines and develop them quickly on an industrial scale by integrating upstream and downstream processes. Where traditional batch processing could take up to seven weeks, continuous bioprocessing could deliver the same product in just one week. The flexibility, speed and consistency this brings will ultimately mean nimble and flexible processes, greater economies of scale and improved efficiency across the board – right through to reducing capital expenditure by limiting the physical footprint needed for manufacturing facilities.
Perhaps most important, however, will be the speed at which biopharmaceutical companies can evaluate the viability of a new product. Providing a methodology by which manufacturers can rapidly assess the quality or utility of complex medicines means that they can screen more candidates and think about a wider breadth of biologic they might bring to the market, which in turn will mean the industry can provide treatments for a far wider array of diseases, to far more people around the world.
A bright future
The move to continuous bioprocessing has the potential to tackle some of the world’s most pressing medicine shortages. Faster mass manufacturing with higher quality yields will help us move towards a drugs on demand model where new medicines are manufactured in locations closer to the patients who need them.
Data analytics and monitoring and the application of cutting-edge automation and robotics have a key role to play in this too. Advances in these key technologies mean we can rely upon increased accuracy across a complex supply chain, with robust data speeding up the process for clinical approvals. Instead of the classic model of regulators approving at each stage of batch processing, we could see the emergence of a more seamless, integrated drug approval process, with huge speed to market ramifications.
The industry is on a journey from traditional stainless steel technologies to continuous bioprocessing. This journey is only just beginning; it will take time for the regulatory environment and industry standards to catch up, and for improvements in processes to tackle, once and for all, any perceived risks around contamination, control challenges and operational complexity. But the tide has firmly turned towards a more continuous approach to biopharmaceutical manufacturing, and a good thing it has too – the benefits that it can bring to the industry, and more importantly to patients, are far too great to be ignored.
Martin Smith is chief technology officer at Pall Corporation