Timing is key and companies that plan before adopting data-driven biomanufacturing are most likely to succeed.

Biopharma is finally starting to show interest in digital manufacturing. The impact of COVID-19 calls for better quality products and continued FDA support for innovative technologies which is helping the normally risk-averse drug industry overcome its conservatism.

According to a recent KPMG survey, 44% of 35 biopharmaceutical companies quizzed have implemented data-driven automation in their manufacturing operations.

Similarly, in a separate survey by Accenture most of the nearly 1,000 executives who took part identified the “profitable adoption of new digital technologies” as their top priority over the next three years.

But going digital in a profitable way is not easy, according to Tiffany Vora, PhD, an expert in biotechnology, medicine, and innovation and current vice chair of digital biology and medicine at Singularity University.

“We are indeed seeing some investments in digitizing manufacturing processes, but as with every other industry, there are potential penalties that come from being the first into an innovation space,” she says.

“My friend and colleague Pascal Finette describes this phenomenon with a metaphor akin to the California Gold Rush. If you think about explorers, pioneers, and settlers, then it’s highly risky for a company to be an ‘explorer,’ and if you’re a ‘settler,’ then you may be too late—all the best turf may already be claimed.”

“The sweet spot seems to be in the ‘pioneer’ phase, right before the innovation becomes massively successful at transforming the problem space.”

Uncertain about implementation

The major hurdle is implementation, according to Vora, who emphasizes that industry is still uncertain about how best to use data to drive manufacturing operations.

“For the past few years, lots of companies have been excited about digital innovation, but uncertain what that means when you get down to brass tacks. I suspect that once we see a few high-profile success stories from digitization in pharma, there will be a rush of industry uptake,” she tells GEN.

“The coronavirus pandemic will also increase the adoption of digital manufacturing,” notes Vora, citing the vaccine sector as a likely beneficiary.

“The ‘COVID bump’ could be very helpful here. Given the vast public uncertainty around vaccines, enhanced transparency and accountability through digitized production pipelines could be a game changer,” she continues.

Biopharma companies should take the time to develop comprehensive digital adoption and implementation strategies to gain maximum benefit from the approach, according to says.

“I believe that the first step must be an organizational mind-set shift: digitization must go from a ‘nice to have’ to a ‘crucial aspect of our business starting tomorrow.’ Again, COVID was a powerful motivator for overcoming classic corporate immune systems. Second, cybersecurity should be pushed to the top of every pharmaceutical company’s list of priorities,” she says.

A degree of knowledge sharing and collaboration would also ease the biopharmaceutical industry’s transition to digital manufacturing, points out Vora, who suggests the FDA, EMA, and other agencies could play a role in fostering such a culture.

“Regulators should convene cross-industry dialogue to keep abreast of experiments within companies, developments in standardization, and more—and to ensure that the public good is kept front and center for all digitization efforts.

But whatever approach biopharma takes, digitizing production in a transparent manner is key, says Vora, adding that “a ‘pharma-lash’ could be far more devastating than today’s ‘tech-lash’ against the tech giants. Overall, I believe that trust is the world’s most valuable commodity. If the pharmaceutical industry embraces that mind-set, then digitization becomes more than a profit protector: it lays the foundation for decades of positive global impact on human health.”