By Geir Rune Flåten, Chief Solutions Officer
To me the 2019 report on Continuous Manufacturing from the FDA, albeit draft, is mostly positive reading. FDA acknowledges the potential in continuous processes and inspires the industry to take steps in this direction. It is in my view helpful to have the FDA outline quality issues and deliver guidelines for the implementation of Continuous Manufacturing. It encourages pharma companies to take more confident steps and not see the authorities as a barrier for these technological improvements. I guess it would really put a heavy lid on digital innovation efforts, if you not only had to invest resources in it, but also had to fear for your compliance and for your overall quality approval at a later stage.
Back in 2004 the FDA published a similar paper on Process Analytical Technology (PAT) as a framework for innovation. 15 years later PAT is still an emerging technology although more and more companies are taking advantage of process analytical capabilities. FDA endorsed the use of PAT in 2004 so you couldn’t blame the slow adoption of these digital concepts on scepticism from authorities. But it shows that the endorsement on a conceptual level not automatically leads to a rapid, industry wide acceptance in the real world of pharma production lines.
“I don’t see the relevance of giving confined spaces to PAT, as it may permeate all phases from development and manufacturing through quality control.”
Gartner’s well known hype cycle for technology comes in mind here. My feeling is, that the FDA hits the top of the hype curve with huge buzz and inflated expectations, when talking about PAT in 2004 and Continuous Manufacturing in 2019. According to the gospel of the hype cycle the technology on the top of the curve will soon after disappoint and be downgraded and move out of public attention. And from this low point it will graduately move in to production, be integrated and be established as the way to do it. PAT is there now, and considering the huge potential, Continuous Manufacturing will hopefully be in this position less than 15 years after this FDA endorsement.
If I should complain about “a hair in the soup” in the 2019 report, it should be the positioning of PAT mostly in the control strategy segment of a Continuous Manufacturing strategy. I don’t see the relevance of giving confined spaces to PAT, as it may permeate all phases from development and manufacturing through quality control. Process analytical technology is to me a crucial building block for the realization of Continuous Manufacturing and the strength lies in many aspects and processes related to innovative manufacturing process design.