Innovation in disposable, single-use manufacturing technologies is a hot topic for the pharmaceutical industry. According to BioPlan Associates’ 13th Annual Report and Survey of biopharmaceutical manufacturing – drug firms want suppliers to focus R&D efforts on disposable technologies.
Managing partner Eric Langer told us: “The desire for disposable bioreactor innovation points to a future in which these will be the predominant devices used in clinical- and commercial-scale manufacturing.
He added that: “Already this year respondents are more likely to say they would implement a single-use than stainless steel bioreactor for a future clinical-scale biologics facility.”
According to Langer, 60% of respondents expect to see a completely disposable manufacturing facility established in the next five years, which is an increase on the less than 50% who made a similar prediction in last year’s survey.
Langer added that: “Almost half of respondents believe that within the next 5 years at least half of their own facilities’ cGMP clinical/commercial unit operations will be substantially done using single-use.”
But while interest may be focused on single use technologies, the vast majority of biopharmaceuticals continue to be made in stainless steel systems according to Langer citing survey respondents’ feedback.
“Although the demand for innovation of stainless steel equipment ranked dead last, cited by just 4% of respondents, this by no means suggests that stainless steel innovation is at a standstill – or that it should be.”
“What the study is indicating is that the single-use equipment still requires further advances for it to be considered a mature, and easily integrated into end-users’ manufacturing strategies."
He also said that combining the two types of systems– hybrid technologies – is driving innovation in the stainless steel technology sector.
“With the industry moving towards more flexible structures, any innovations that can serve to make stainless steel facilities more modular will also be welcomed in the near future. This includes automation, and more robust applications.”
Choosing between single-use and stainless steel is still difficult for the drug industry. Survey respondents cited factors like desired yield, the availability of technology and the ease of combining such systems as key to any decision.
According to Langer firms finding it hard to weigh up these variables could do worse that asking the advice of a contract manufacturing organization (CMO) as contractors’ desire for flexibility is an important innovation driver.
“Contract manufacturing organizations (CMOs) continue to be at the leading edge of innovation and process improvements. So we look to them to define how the future of mainstream bioprocessing will look in 5 and 10 years. The segment continues to evolve with new devices and new applications for implementation and integration.”
Eric Langer will be chairing a roundtable entitled “Deciding on a single-use vs. stainless steel strategy” at Interphex on April 26, 2016.