In Part II, GEN continues our discussion with Carla Reinhardt, project lead at Johnson & Johnson (Cork, Ireland), who surveyed Irish biomanufacturers on their awareness of Biopharma 4.0. Part I can be found here.

Reinhardt’s findings are in line with industry reactions to previous “next big things”—FDA modernization efforts that include process analytics, quality by design, and risk-based manufacturing, plus parallel initiatives in “green” technologies and lean/six sigma.

Specifically, everyone gets excited about these new paradigms but years after the big announcements little often has been accomplished. Compare, for example, enthusiasm over the years for PAT or QbD compared with single-use bioreactors.

GEN: What are the barriers of awareness or adoption of Biopharma 4.0?

Reinhardt: That the most-aware respondents were in engineering or automation points to the silo mentality which prevails in our industry and prevents the fruitful sharing of knowledge within organizations. Companies are attempting to break down these walls to encompass inputs from maintenance, IT, finance, and quality groups as well as from engineering. Although some of these companies had been involved in some signature 4.0 technologies, even individuals in manufacturing were unfamiliar with 4.0 as a whole.

GEN: What can we do about this lack of awareness?

Reinhardt: Companies hoping to stay ahead of the curve need to address gaps in 4.0 awareness through education. It’s important to raise awareness from the bottom up. Leadership commitment alone will not get this done.

GEN: We’ve previously seen slow adoption of new manufacturing paradigms. What other hurdles to wide-scale adoption of 4.0 do you notice?

Reinhardt: Inertia is a big impediment to change. There’s also a great deal of uncertainty, and fears that 4.0 could be a big investment “black hole.” Companies will invest if managers can be convinced that the added operational value will increase profits. But this is more difficult to do when processes must adhere to GMPs and other standards, so you can’t just change things without careful planning.

GEN: They say every journey begins with a first step. Many companies have already taken it by implementing individual components of Biopharma 4.0. What’s next?

Reinhardt: These technologies work, and leadership has bought in, but implementation could cost more than anticipated because research on implementation in regulated environments is lacking. There is also the issue of scale. Adopting 4.0 in one suite at one site may cost tens of thousands of dollars, but plant-wide deployment or implementation at ten facilities will cost millions. What looks great at the project level can cost millions at the plant level and beyond. These big deployments cannot happen without a willingness to take risks.

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