Medicine manufacturers are only just beginning to realise the benefits of shifting from traditional batch-based production to continuous bioprocessing. When the industry finally embraces continuous manufacturing, writes Pall Corporation’s Chief Technology Officer, Martin Smith, we’ll wonder why we didn’t do it sooner
From automotive to food and metal production, most industrial sectors have already adopted continuous manufacturing processes ... and the benefits they’ve seen have been transformative. Increased efficacy, decreased capital costs, better reliability, reduced failure rates and improved control have ultimately sped up the process of bringing new products to market.
The biopharmaceutical industry has historically been slow to adopt a more continuous culture. It wasn’t until 2015 that we saw the first continuous process for a small-molecule drug product gain regulatory approval with Vertex’s Orkambi.
There remain concerns regarding the perceived risk of contamination and control issues, which has led to a broader unwillingness by the industry to venture into the unknown. This has slowed the pace of change for biopharma.
Now, finally, the shift is starting to happen and we’re seeing the true potential that continuous manufacturing processes hold for the industry. From a patient perspective, continuous bioprocessing’s ability to expedite and industrialise the development of “drugs on demand” could have a transformational impact on healthcare worldwide — opening the door to an era of truly personalised production of high precision medicines.
Meanwhile, for medicine manufacturers, the possible cost benefits of moving to continuous processes are difficult to ignore.
With manufacturers facing increased cost pressures, greater competition and public criticism for medicine shortages, the issue of manufacturing effectiveness has climbed the biopharmaceutical industry agenda. Finding a more efficient way to ensure the right patient receives the right medicine at the right time is now critical to longevity, profitability and survival.
Compared with batch processing, the efficiency improvements associated with continuous bioprocessing are evident at every step of the way. With continuous operations, manufacturers immediately see a marked reduction in single-use component turnover — thanks to higher throughput dynamics as an alternative to scaling-up.
Take Protein A chromatography sorbent, for example, which, using traditional methods, would normally be discarded after several batches.
By spreading the process operation across multiple small columns in parallel, continuous chromatography steps can reduce the need for this sorbent by up to 90%. This vastly improves the efficiency of consumable use, while also reducing the need for large tanks, buffer storage bags and other equipment — all of which takes considerable cost out of the manufacturing process.
Manufacturers also see much higher utilisation rates for equipment and facilities when using continuous systems. With traditional batch processing in a large, stainless steel bioreactor, for example, as much time will be spent on cleaning and changeover as it will on actual production.
Continuous, meanwhile, allows manufacturing assets to be run 24/7, 365 days a year, with huge benefits in utilisation and efficacy. Ultimately, continuous bioprocessing will reduce the average size of manufacturing facilities, meaning smaller workforce requirements and lower capital expenditure.
The industry is still at the start of its journey towards truly continuous manufacturing. Medicine manufacturers are now going through “process intensification” steps, whereby clusters of unit operations are being brought together and compacted.
But more and more, they are asking us at Pall to develop an end-to-end continuous process for them — a sign that things are finally moving in the right direction.
Setting aside the huge financial benefits that manufacturers will see from improved utilisation and efficiency, where we’ll really see continuous bioprocessing impacting the industry globally is in how quickly new, complex medicines can be developed on an industrial scale.
Whereas traditional batch processing could take up to 7 weeks, continuous bioprocessing could deliver the same product in just 1 week. This will vastly improve the speed at which biopharmaceutical companies can evaluate the viability of a new product, allowing them to accelerate the production of clinical trial material and reach potential failure points sooner, reducing the cost impact of failed drugs.
From the perspective of the patient, the move to continuous bioprocessing has the potential to transform medicine supply for people worldwide.
It will help to tackle some of the world’s most pressing medicine shortages, enabling a move towards a drugs on demand model whereby new medicines are manufactured in locations closer to the patients who need them.
Coupled with the huge efficacy benefits it will bring to the companies manufacturing these vital medicines, we need to recognise the simple fact that continuous bioprocessing is now a viable value driver for those companies who are prepared to truly innovate … and too great an opportunity to be missed.