_More and more drug companies are recognizing the benefits of digital manufacturing operations with Novartis and Sanofi being recent examples. Both firms cited a desire for more efficient production and flexibility as the drivers for the investment.

For John Klaess, PhD, content marketing specialist from manufacturing software developer Tulip, digital manufacturing fits with industry’s need to reduce costs and improve product quality.

“Digital can help quality, traceability, time-to-market, and compliance. It’s also useful to think in terms of capabilities,” he says. “Digital can help biopharma manufacturers increase system flexibility without increasing risk. It’s an opportunity to address dozens of inefficiencies that many manufacturers come to accept, as well as to identify trends and analyze data.”

And the trend will continue, according to Klaess, who adds, “I think we’re at an inflection point in biopharma. The companies that are investing in digital manufacturing are starting to see it pay off. Digital will become more of a differentiator as time goes on.”

Document mindset

But to take full advantage of digitization drug companies need to take a holistic approach rather than focusing solely on manufacturing, Klaess says.

“A more complete embrace of digital manufacturing means moving away from paper and the ‘document mindset’ that’s still common, towards a broader acceptance of other forms of digital documentation,” he explains.

“It’s also important to remember that digital manufacturing is as much about helping people solve complex problems as much as it is connecting assets and processes.”

Implementation is the biggest challenge drug companies face when adopting a digital strategy.

According to research published in the International Journal of Production Economics, “The organizational context and environmental context impact implementation, these impacts are mediated through the technological context of the firm.”

Klaess agrees, adding that firms that already use modern data management practices are usually better able to implement digital manufacturing operations.

“It can be challenging if you try to start with too large a scope. Biopharma is already quite automated with large DCS systems. The challenge is filling in the gaps,” he continues. “It’s also important not to underestimate the fact that setting up digital process also requires a process of culture change.”

Finding the right control technology is also vital, notes Klaess, adding that while a wide range of digital systems are available for individual unit operations, choice is limited when it comes to management platforms.

“There are plenty of point solutions that solve single problems, as well as large systems. But biopharma lacks systems that balance breadth, control, and flexibility. They need systems that can both ensure compliance and quality, but also allow for continuous problem solving without expensive customizations,” he says.

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