The bioprocessing industry, and many others, focus on working smarter—perhaps now more than ever.

“Smart manufacturing represents an industry-wide paradigm shift in how companies design, make, and distribute products, from lifesaving medicines to cutting-edge electronics,” says Michelangelo Canzoneri, PhD, who serves as the global head of group smart manufacturing at Merck KGaA, based in Darmstadt, Germany. “In our case, it’s set to drive a profound transformation across the industrial landscape, unlocking far-reaching advantages, and that resonates throughout all companies, including the supply chains, and ultimately it will benefit people, patients, and our whole planet.”

Building such a global impact, though, depends on implementing changes in many areas.

“The journey from traditional MANUfacturing to SMARTfacturing represents transformation of all operations by integrating advanced digital technologies, [information technology (IT)/operational technology (OT)] convergence, and AI-driven intelligence with established process and analytical methods. This shift enables us to address current challenges while proactively preparing for future disruptions,” Canzoneri tells GEN.

In an era of rapidly changing market conditions, SMARTfacturing must be highly adaptive.

“We envision a future of modular, reconfigurable factories capable of dynamically adjusting production processes, product designs, and logistics in response to shifting demands,” continues Canzoneri. “These intelligent facilities feature reconfigurable production lines composed of adaptive robotic systems, flexible automation cells, and self-diagnosing machines that can optimize energy and resource utilization.”

For example, equipment in a SMARTfacturing facility can predict maintenance needs and seamlessly collaborate with supply-chain networks in real time.

Merck KGaA has developed a vision of a SMARTfacturing ecosystem. [Merck KGaA/Darmstadt, Germany]
Merck KGaA has developed a vision of a SMARTfacturing ecosystem. [Merck KGaA/Darmstadt, Germany]

Merck KGaA has developed a SMARTfacturing vision ecosystem, which is a structured, multi-layered framework integrating advanced and modular manufacturing technologies, data-driven decision-making, and automation/robotics. This SMARTfacturing model provides a holistic view of transformation in operations, defining the why, what, and how behind the company’s strategy, explains Canzoneri.

 

At the core of this vision is a holistic control tower, enabling decision intelligence through AI, real-time data insights, and predictive analytics. This digital backbone allows Merck KGaA to optimize manufacturing, logistics, and supply-chain processes, which unlocks new opportunities in product innovation, sourcing strategies, and data-sharing, according to Canzoneri.

“Accessing data in a systematic way enables a deeper understanding of challenges and the ability to drive meaningful improvements,” he says. “Our approach is centered on addressing critical business challenges—both existing and emerging—while continuously enhancing our processes and solutions.”

This transformation is supported by key technology enablers, including process science and technology, connected industrial equipment (convergence of IT and OT), and engineering and automation, underpinned by quality, regulatory compliance, IT/OT cybersecurity, and workforce readiness. By integrating these elements, Merck KGaA aims to be a major player in shaping the future of smart, data-driven, and sustainable manufacturing.

From 2022 to 2024, the manufacturing industry in general made big strides in the transition from predigital to adaptive plants. “Things are moving quite fast,” Canzoneri says. There are many good reasons to continue this transition. For example, Canzoneri   points out that SMARTfacturing could decrease maintenance costs by 25% and increase labor productivity by 90% based on industry benchmarks.

However, the biggest challenge is building a solid digital foundation to ensure fast scaling and quick adoption of SMARTfacturing capabilities. This foundational work is crucial before advancing to more complex digital capabilities and implementations. “Once this foundation is in place,” explains Canzoneri, “you can fully leverage AI, automation, and data-driven insights to accelerate time to impact and innovation.”

Although going from predigital to SMARTfacturing takes time and investment, the process pays off, he says, adding that the company’s commitment to SMARTfacturing is more than an operational shift; it’s a long-term investment in industrial excellence and sustainability.

“Scaling the adoption of SMARTfacturing will not only enhance operational resilience but also enable us to deliver innovative solutions faster, with greater precision and sustainability,” Canzoneri concludes. “Ultimately, this transformation benefits our customers, patients, and the planet.”

 

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