A market report from industry body DECHEMA – Germany’s Society for Chemical Engineering and Biotechnology – has predicted that single-use systems will continue to grow on a sustained basis by more than 15% annually.
The paper was published this week at ACHEMA 2015 in Frankfurt, and while vendors at the show – unsurprisingly, perhaps - agreed the shift to single-use continues, Merck Millipore told Biopharma-Reporter.com it is the smaller biotechs and start-ups anxious to keep control of both their manufacturing processes and their costs which is propelling the growth.
“SMEs taking a single-use pathway can retain ownership of their processes for a longer time, rather than outsource to a contract manufacturing organisation of be forced to invest in a capital intensive stainless steel facility,” said EVP of Process Solutions Andrew Bulpin.
Market access and increased product titres
Such companies are one of Merck Millipore’s (known as EMD Millipore in North America) core customer groups, though he added the firm is seeing uptake from across the spectrum as single-use presents market access opportunities.
With certain countries – Brazil, Russia for example – demanding drugmakers to conduct a percentage of production locally, single-use gives firms a cheap and flexible access to the market, he continued, so “irrespective of the size of a company, when looking at a new projects or geographic expansions then single-use is clearly the go-to option.”
He also echoed other reports and commentators with the opinion that increased expression levels achievable with the latest disposable systems are further encouraging universal uptake:
“First generation single-use bioreactors were producing around 200mg/L, while the latest are upwards of 5g/L. That’s a 25-fold increase.”
Merck’s 2,000L bioreactor
In such an environment, Merck is launching at ACHEMA this week the Mobius 2000L single-use bioreactor, its first foray into a system of this size, viewed to be at the larger end of the disposable range.
Bulpin acknowledged Merck was far from the first vendor to bring a bioreactor of this volume to market – nearly all its competitors including GE Healhcare, Pall, Sartorius and Thermo Fisher already have single-use systems of this size available – but told us it had “listened to the voice of customers as to he weaknesses of first generation systems, and thus addressed them with this product.”
The benefits of the Mobius, he explained, are its bottom-loading drawer making it easier to load the system with consumables, shaft-free impeller eliminating need for operator intervention, and its built-in ‘X’ shaped baffle that avoids vortexes and dead-zones in the mixing.
Furthermore, the system has a 5:1 turndown ratio which Bulpin explained meant it could be operated at anything from 400L upwards, making it a useful system for firms looking to use it for a pilot run or a scalability model.