Single-use technologies was one of the key topics at this year’s BioProcess International European Summit with a number of leading industry figures putting it in the spotlight.
“From hypothesis to market it takes an average of 10 years & $2.7 billion per drug, which puts a lot of pressure on bioprocessing.”
In a single sentence Wolfgang Kuhne, Vice President Technical Development Bioprocessing and Clinical Supply at Roche Diagnostics, highlighted the key problem facing the biopharmaceutical industry today. It is no wonder then that the promise of reduced costs and greater flexibility makes single-use technologies an increasingly attractive prospect for many.
Traditionally there has been a disconnect between the risk a drug won’t make it to market and the amount of money needed to start building facilities, but as Parrish M. Galliher, CTO Upstream at Xcellerex at GE Healthcare Life Sciences, emphasised at the event in April, “there is a certain amount of risk mitigation that single-use technology has provided”. Indeed, GE’s figures show that single-use implementation results in an average 32% saving on costs and a 30% increased capacity.
Galliher sees a future where very large stainless steel facilities will still exist for the manufacture of blockbuster drugs, but for mid-sized production (up to 1500kg per year) single-use concurrent multi-product manufacturing will be standard.
Ron Bates, Director at BMS, was similarly evangelical, arguing that “single-use is a great opportunity to simplify drug development”. Furthermore, as the technology continues to develop, he questioned the very definition of the term, explaining “anything can be single-use if the economics are favourable”. “What about limited use rather than single-use? Why not two or three lots instead of just one?” he added.
Away from any financial risk mitigation, a number of other single-use benefits were introduced. With biotech pipelines and drug diversity increasing, flexibility is set to become more and more important, with single-use offering the most viable solution. Equally, Bates underlined: “What’s really hard to put a number on, but is very important is how single-use reduces contamination”, whilst Berthold Roehrich of Parker Hannifin added: “For complex single use systems, standardisation will reduce cycle times and result in more robust systems.”
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