A roundtable talk at the BioProcess International Summit in Vienna, Austria this week focused on the facility of the future, with single-use technologies and continuous biomanufacturing dominating the discussion.
But while chair Kumar Dhanasekharan – director of process development at CMO Cook Pharmica – argued the future would not be based on stainless steel, Biopharma-Reporter.com questioned whether ongoing large investments in this traditional technology by the likes of Biogen, Samsung Biologics, Boehringer Ingelheim, and Rentschler meant this is actually the case.
“If you look at the number of facilities that have been built over the past ten years, the numbers are clearly going the way of more modular, smaller scale systems,” Dhanasekharan said. “The numbers are overwhelmingly in favour of single use bioreactors and sales [of such systems] have skyrocketed in the last five years, and this trend continues to happen.”
He added that there would always be a need for stainless steel - for example in manufacturing commercial scale blockbusters - but such systems are becoming the minority.
“A few years ago single use was the niche, with few people adopting single-use and there was a lot of investment in stainless, but today that trend has shifted and the pendulum has really swung the otherway.”
Cook has a hybrid facility in Bloomington, Indiana. “If we were thinking of upping capacity by either building a 15,000L bioreactor capacity or a single use facility, I think we’d be moving towards a single use facility at 2,000L scale,” Dhanasekharan said.
Continuous creating comeback?
Much of the rest of the discussion focused on continuous manufacturing which participants agreed had come on leaps-and-bounds over the past two decades, with some believing it will be a standard process within five years.
But if and when technology allows upstream perfusion technologies to seamlessly integrate with continuous capture tech in the downstream, the question was posed as to whether stainless systems could make a return.
Some of the main advantages of single-use systems are the quick turnaround times and the reduced risk of cross-contamination, but once biomanufacturing is in a steady state it should not matter if the equipment is disposable or not.
“If you have a stainless facility and you run it in a continuous mode, then whether there are any benefits or not is somewhat unknown,” said Dhanasekharan.
However, he argued that the smaller scale and portability of future demand means continuous production “begs to be single use, especially as the technology is already available.”
He continued: “The supply is going to be based on the campaign’s need, so if you need x amount of material per year, you can probably make that campaign in two months and be done. So is there a benefit of stainless steel? Perhaps not, but if you can put it together as quickly as a single-use system, then my guess would be [it could be] a viable option.”