Drug manufacturing is changing. After decades of inertia during which firms have opted for established technologies rather than adopting new manufacturing systems, industry is finally starting to recognize the benefits of data-driven production.

Cost and product quality are the major change drivers, according to Frank Lesmeister, expert partner at consulting organization Bain & Company, who says biopharma is comfortable with the industry 4.0 concept.

“Manufacturing 4.0 can be described as the convergence of people, physical systems, and data within a biopharma manufacturing process to increase quality, productivity, and profit, by using the power of advanced data analytics,” he says.

In April, Lesmeister co-authored a study on the emergence of digital manufacturing in biopharma. The team interviewed biopharmaceutical industry executives and the feeling is that industry 4.0 tools can lower costs by as much as 20%.

“They see a big need for—and many potential benefits of using—new, digital technologies in the pharma industry,” points out Lesmeister, adding that “most biopharmaceutical companies are in early stages of testing or implementing these technologies.”

Executives quizzed for the study predicted that digital manufacturing technologies will improve product quality and reduce wastage, thereby further decreasing production expenses.

They forecast an average 17% reduction in costs related to poor drug quality, a 15% decline in costs associated with converting raw materials into biopharmaceutical products, and a 14% increase in output.


The respondents also acknowledged that adopting digital manufacturing technologies is a complex process, with the biggest challenge being how to ensure the various systems are able to work in unison.

Having the underlying technologies in place before setting up the manufacturing systems is key, according to Lesmeister.

“Often companies struggle because they have not implemented a manufacturing execution system (MES), which is a prerequisite for more advanced digital technologies,” he says.

The process can also be made easier by adopting manufacturing processes that minimize waste from the outset.

“Implementing a production-performance manager system is relatively easy for companies that already have installed a MES and use lean manufacturing techniques,” continues Lesmeister.

Competitive advantage

Another potential issue facing firms who are thinking of going digital is ensuring that their manufacturing staff are trained appropriately.

According to the study, 64% of respondents see helping manufacturing staff achieve the “required behavioral changes” would be a challenge, with a further 58% raising the “lack of required skills” as a concern.

“Firms adopting digital manufacturing need to invest in people and capabilities,” advises Lesmeister to avoid such issues.

Nevertheless, in his opinion, adoption of data-driven manufacturing will continue to accelerate.

“Industry 4.0 technologies will change pharma manufacturing processes dramatically in the next five years. Companies that get started now will have a head start in creating a competitive advantage,” he adds.

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