Novartis, like many of industry peers, has been talking about digitization a lot in recent years. In 2018, the company outlined a plan to “go big on data and digital,” committing to use technology and analytics to make R&D, commercial and manufacturing operations more efficient.

More recently the Swiss firm partnered with AWS, Amazon’s digital industrial services business, to digitize its manufacturing systems and supply chains.

Data-driven mind set

For companies with the right culture and infrastructure, the potential benefits of digital manufacturing are considerable according to Francisca Gouveia, PhD, who is a senior process expert at the Swiss drug maker’s facility in Huningue, France.

“The emergence of a data-driven mind set and the advancements in computer science and digital technologies are an opportunity to gain novel insights to boost process efficiency,” she says. “In the commercial biomanufacturing area, data and digital technologies are starting to gain traction to identify yield and quality improvements, tackle supply chain volatility, streamline operations and accelerate process transfers.

“The real-time revolution, the ability to analyze data while it’s being produced, allows closing the gap between data collection and decision-making. This possibility is set to alter the way control strategies in biomanufacturing are driven on the shop floor–from a reactive to a proactive approach.”


Some potential “quick wins” include early fault detection that will help manufacturers reduce costs. And going forward, the benefits of an effective digital manufacturing strategy are likely to be even more significant, notes Gouveia.

“On a long-term perspective, data and digital technologies significantly contribute to understand the underlying relationship between process parameters and product quality attributes so that this variability can be compensated in an adaptable manner to deliver consistent product quality and significant yield improvements,” she continues.

“Adaptation is key to competitiveness: the realization of the Industry 4.0 paradigm encompasses the definition of an adaptive control strategy in biomanufacturing.”

Drug quality

The likely impact on product quality is another potential benefit of the digital approach.

“The conventional manufacturing paradigm focused on quality by testing (QbT) is still deep-rooted in the quality culture of biopharmaceutical companies due to the complexity of unit operations and production infrastructures,” explains Gouveia. “Although final product testing is an important element of quality control, regulatory bodies have embraced the paradigm shift of quality built into the processes producing the products–Quality by Design (QbD).”

She points out that while documents and guidelines like ICH Q8-Q12 explain why industry should consider quality at the design stage, recent advances in digital technology have finally provided a way of doing something about it.

“On the technology domain, significant improvements in retrieving, visualizing and managing data sources of very different complexity will encourage biopharmaceutical companies to implement more advanced data analytics and deployment of digital solutions in manufacturing,” she tells GEN.

“Digital manufacturing is perhaps the most promising differentiation strategy that will allow biopharmaceutical companies to increase competitiveness and adapt to changing market demands.”

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