At the BioProcess International Summit in Dusseldorf, Germany earlier this month, speakers and delegates were confident industry had successfully implemented single-use equipment across a range of bioprocesses, and would grow increasingly important in the facility of the future.
After Baxter carried out a comparison study between single-use and stainless steel, Head of Technical Operations Plasma Geoffrey Pot said using a disposable plant brought the company a number of benefits, including a reduction in size of production area needed and an equivalent output of product.
(The study compared 2x2,500L stainless bioreactors with 2x2,000L and found only a 10% difference in output, despite a 20% difference in capacity)
Furthermore, Pot continued, the study showed even though material costs of single-use were 35% more than with stainless steel, the overall cost was reduced by needing fewer personnel, utilities (mainly due to lack of CIP - Clean-in-Place Systems) and significantly lower CAPEX.
This will become increasingly more important as cost pressures from healthcare providers increase, he added, as well as new markets opening up which will require a level of speed and flexibility in construction not available with stainless steel.
Glenmark, for example, recently opened a fully single-use plant in Switzerland and from construction to operation it took only a fraction of the time associated with traditional stainless plants, Senior Process Engineer Albin Simoni said in a separate session.
“After this first campaign we had an inspection and got the GMP certification within 16 months.”
Boehringer-Ingelheim is also opening a mammalian cell facility in Shanghai, China which will mean the Germany-based firm will have over 200,000L of mammalian cell capacity - plus over 12,000L microbial – across its worldwide network.
Global Head of CMC Strategy Jens Vogel said the Shanghai site will be fully disposable after deploying single-use systems at sites in in Biebelach, Germany and Freemont, US.
“In the future you can imagine that technology will be developed with fast deployment that would allow us to go into the emerging markets, to support personalised, precision medicine where we have a small patient population…. disposables will be a real advantage.”
But despite this, he told delegates “at the end of the day though, for us, disposables will not replace stainless.
“For large volume products it’s almost impossible to compete with an existing plant that you have sitting there that in some cases is already fully depreciated and which works very well,” he said, “so it is a matter of what volume and the number of batches you need.”
Pot agreed: “Single-Use has many advantages for low volumes and multi-product facilities, but at a certain volume level, single-use is not very useful anymore.”