The Industry 4.0 concept has been around since 2015. Writing in Foreign Affairs World Economic Forum (WEF), chair Klaus Schwab predicted that advanced, intelligent technologies and automation would revolutionize manufacturing processes across a range of industries.

Since then the approach has become established with the automotive, aerospace, and food and beverage sectors being the quickest to implement 4.0 ideas in their manufacturing operations.

However, adoption of Industry 4.0 in biopharma has been slower, according to Mark Duerkop, who co-founded bioprocess development software firm Novasign in 2019. He says the rules and requirements governing drug production have made it more of a challenge for the biopharmaceutical industry to embrace innovation.

“I believe Industry 4.0 will bring the same benefits to pharma as we see it in other maybe less regulated industries already today: better process understanding, reduced development timelines, and reduced economic footprint,” he tells GEN.

Another hurdle is pharma’s lack of “digital maturity,” Duerkop adds, citing a 2016 study by McKinsey in which the drug industry ranked second lowest ahead of the public sector in terms of the use of digital technologies.

“Since digital maturity and Industry 4.0 correlate, I believe this is the steep learning curve pharma has to take. So honestly, I believe it’s time to first fully implement Industry 3.0 until we enter the next stage,” he notes.

Motivation

Industry 3.0 is defined by data. The basic idea is that information is gathered during each unit operation and collated to create an overall picture of the process.

Industry 4.0 takes this data and uses it to create experimental models for optimization to empower automated control and real-time monitoring.

To be 4.0-ready biopharma companies must invest in systems able to gather and transfer data. They also need to establish an information management architecture.

Whether biopharma, which has traditionally sought to minimize capital expenditure (CapEX), will make such investment remains to be seen. However, according to Duerkop, efforts to combat the coronavirus pandemic suggest industry may innovate with the right motivation.

“We just saw several COVID-19 vaccines entering the market in just one year, which is almost one-tenth of what is typical for other drugs. With increased risk by reduced clinical timelines and accelerated authority evaluation, much more pressure is set on the process development and manufacturing,” he points out.

“If we want to fully adapt to accelerated timelines, increased process understanding, and reduced batch rejections we need methods to help us faster and better understand our processes. The time for meaningful parallelization, process modeling, and rational knowledge transfer has come.”

Duerkop cites SARS-CoV-2 vaccine development work by BioNTech and Moderna as evidence of what biopharma will do with the right motivation.

“The advantages of mRNA technology for vaccine development over classical approaches was often considered, but it required the pandemic to quickly display the full potential,” he says. “So I believe we will also see the full potential of bioprocess-related technologies like process modeling or continuous manufacturing once the pressure on the development further increases.”

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