Sanofi's Digitalization Road Trip Shifts Into High Gear

A conversation with Brendan O’Callaghan, Sanofi

Sanofi’s digital and modernization strategy takes aim at a steadfast issue in biopharmaceutical manufacturing — shortening the time it takes for facility changeovers.

Much of the company’s manufacturing strategy points to trimming to swap equipment, teams, and techniques for one molecule, modality, or platform and getting them ready for the next. In fact, Sanofi brought in the world’s greatest changeover artists, a Formula 1 racing pit team, to think further outside the box. More on that later.

The company’s head of manufacturing, Brendan O’Callaghan, will speak at the International Society for Pharmaceutical Engineering’s (ISPE) 2025 ISPE Annual Meeting & Expo about the big picture and drill down on specific initiatives speeding them along the way. He agreed to give us a preview and answer some specific questions.

Sanofi has made sizable investments in digitalization, automation, and AI. Can you walk us through a few flagship initiatives? Where have you made the biggest bets? What measurable effects have you seen so far in terms of throughput, quality, and agility?

O’Callaghan: To understand how unprecedented our level of ambition in our space is, allow me a word of context. At Sanofi, we’re looking at over 30 potential product launches in the next five years. That’s not just a pipeline goal — it’s our operational reality. And the role of manufacturing and supply is to take those scientific breakthroughs and make them real, to get them into the hands of the patients who need them.

This is the reality underpinning our ambition to become the first biopharma company powered by AI at scale. This is why across our manufacturing and supply network, we are accelerating modernization and digitalization to create a future where breakthrough immunology medicines and vaccines reach patients faster than ever before. Because for them every second counts.

We have many flagship initiatives underway. We’ve invested over a billion euros in building our next generation Modulus facilities in France and Singapore. These two sites are, in many ways, our blueprint for the future, digitally enabled end-to-end. They’re a complete rethinking of what biopharma production can be. What makes them different is the level of agility. Traditional sites are built to manufacture one product — or one class of products — at scale. Switching between platforms or product types takes months, sometimes years. But a Modulus facility can enable the simultaneous manufacturing of multiple vaccine and biologic types, allowing production to switch between platforms in days or weeks instead of months or years.

We also launched last May what we call our Digital Manufacturing & Supply Accelerator in Lyon, France, bringing together experts in AI, data scientists, and process engineers to identify high-value use cases and then industrialize them at speed. One good example is our use of digital twins. This allows us to simulate an entire production process before the line is even physically built, consistently shaving two to three months off the deployment timeline for new lines. We pilot and test such digital solutions in what we call our lighthouse sites to help us accelerate our operational performance to best-in-class levels, comparing with industry benchmark.

Another innovation is SimplY — our proprietary AI-powered system that uses telemetry from sensors across our bioreactors and production lines. It tracks thousands of data points in real time, which allows us to optimize yield and performance batch by batch. We’ve seen gains of 5% to 10% in production yield. That’s not theoretical — those are extra doses that reach patients faster. That’s how AI becomes not just a tool but a driver of patient impact.

Standardization is notoriously difficult in light of a general lack of cooperation among vendors. Are there specific platforms, governance structures, or procurement practices you've adopted to reduce fragmentation?

O’Callaghan: Standardization, simplification, and digitization have all been key to breaking down silos and adopting global and efficient standards to accelerate our path to a digital future. At Sanofi, we've taken a strategic approach to address these challenges across our manufacturing network. Our success in reducing fragmentation stems from establishing strong digital foundations and governance structures that promote integration and scalability.

First, we've implemented what we call our standard digital foundations across key operational pillars: QualiPSO for quality management, iShift for ERP, MARS for manufacturing execution, and advanced planning systems for supply chain planning. This standardized core creates a unified digital backbone that ensures consistency across our 39 manufacturing sites worldwide.

To drive this transformation effectively, we've established our Digital Manufacturing & Supply Accelerator in Lyon, which serves as a central hub for developing digital initiatives, supporting new product launches, accelerating efficiency in manufacturing and ensuring standardized deployment across our network, starting with our digital lighthouses. Our most advanced manufacturing sites, where technology-driven industrial transformation has significantly enhanced operational performance, are located in Geel, Belgium; Waterford, Ireland; Scoppito, Italy; Toronto, Canada; and Hangzhou, China. These lighthouses exemplify the power of connected smart factories, showcasing advanced digitalization and automation. They demonstrate the value of full digitalization and serve as benchmarks for other sites, enabling the rapid adoption of AI-driven solutions such as predictive downtime optimization, adaptive process controls, in-silico bioprocess experimentation, and launch readiness simulation.

Solid data foundations are also key to our ambition of becoming the first biopharma company powered by AI at scale. And for the past few years, we have made tremendous efforts in building standard data foundations enabling us to reconnect all data sources that unlock previously hidden data to provide deeper insight and further context for our AI systems.

Through these initiatives we're creating an integrated ecosystem that enables us to accelerate innovation while maintaining the rigorous quality and compliance standards essential in pharmaceutical manufacturing.

Sanofi built a custom MES and smart factories. Smaller companies may see these as out-of-reach luxuries. Can resource-constrained companies still borrow from your approach? Are there specific digital tools or automation layers that offer greater returns without the full-scale build-out?

O’Callaghan: For smaller companies, there are solutions available to match their scale, and especially now the opportunity to harness the rapid expansion of AI. The beauty of digital transformation is that it's not an all-or-nothing proposition — it's a journey that can be approached incrementally with targeted investments in high-value areas, much as we explore pilot solutions in our lighthouse sites, before scaling them to our global network.

First, I'd recommend focusing on sensor technology and data capture. We've seen remarkable returns from putting sensors on production lines to monitor performance parameters like vibration, temperature, and electrical pull. This telemetry approach, inspired by our McLaren Racing partnership, has improved overall equipment effectiveness (OEE) by 20%-25% in some of our lines. Even a modest sensor deployment can yield significant insights without requiring a complete factory rebuild.

Second, consider targeted AI applications that solve specific pain points. At Sanofi, we have a three-pronged approach using AI, with Expert AI powering our scientists in the labs, Snackable AI providing our teams with data-driven insights to guide decisions for better outcomes, and generative AI automating low-value tasks, improving productivity, and simplifying the everyday life at work. For instance, our SimplY system mentioned before, which optimizes manufacturing yield, demonstrates how focused AI can deliver substantial value. By analyzing control parameters from your best-performing batches and replicating those conditions, we've achieved significant production yield improvements. For smaller companies, similar yield optimization tools can be implemented at individual process steps rather than across an entire facility.

Our journey didn't start with fully automated smart factories. We began with targeted use cases, proved their value, and scaled from there. The key is identifying where digital can solve your most pressing challenges and starting there — with a clear focus on patient impact and measurable outcomes.

SMS2.0 and smart factory initiatives are cornerstones of Sanofi’s modernization push. What were some of the hardest technical or organizational hurdles in building and scaling SMS2.0 across sites? And how do you ensure consistency in deployment while still allowing local flexibility

O’Callaghan: The implementation of SMS2.0 (Sanofi Manufacturing System 2.0) and our smart factory initiatives have indeed been pivotal in our modernization journey and the scale-up of our initiatives. But while the technical challenges were obviously significant, like technologies’ diversity, I actually believe this is not just about technology but more about people and culture.

In our plants, you can have individuals with decades of experience in pharmaceutical operations — people who have literally written the playbook on how to run high-quality, validated manufacturing environments. And now we’re asking them to work alongside digital natives who come from tech, startups, or adjacent industries. These are people who move fast, iterate quickly, and think in terms of code and data.

The key has been mutual respect — and co-creation. We don’t parachute in digital solutions and expect them to work. We embed digital teams directly into the manufacturing context. We organize around what we call pods — small interdisciplinary teams that include process engineers, operators, data scientists, and software developers. Everyone is accountable. Everyone learns from each other. Solutions are based on data driven insights, not on the opinion of experts or based on organizational hierarchy. This drives true empowerment.

Of course, there are always growing pains. But there’s also a growing sense of shared purpose. When people realize that their ideas — whether from the shop floor or the coders community — can materially impact how fast we get medicines to patients, something powerful happens. The silos start to dissolve.

Ultimately, our goal is not just adoption, but transformation. By fostering a culture of continuous improvement, empowering our teams with the right mindset and tools to remove emotion through data driven solutions, we're building a manufacturing network that's not only more efficient but also more adaptable to future challenges.

You mention partnerships as part of Sanofi’s digital and AI strategy. Can you elaborate? What types of partners (e.g., tech, academic, consulting) have been most effective and why?

O’Callaghan: Our partnership strategy has been a cornerstone of Sanofi's digital transformation, bringing fresh perspectives that challenge our thinking and accelerate our progress. While we've developed significant in-house capabilities, strategic partnerships have been instrumental in helping us reimagine what's possible in pharmaceutical manufacturing.

Our most impactful partnership has been with McLaren Racing's team, which might seem surprising at first glance. But the parallels between F1 and pharma manufacturing are striking — both require precision, speed, and performance under pressure. McLaren brought us a mindset of continuous optimization and real-time telemetry that has transformed our operations. Their engineers helped us improve changeover times on our production lines by up to 40% through real-time AI video analysis and achieved 10-times productivity gains on a series of manufacturing processes.

On the digital front, we've also partnered with specialized big or small tech companies that bring unique approaches to specific challenges (cloud infrastructures, core business digital foundations, data foundations), moving beyond traditional client-supplier relationships to true co-creation models. It enables us to leverage best practices, to digitize at speed and at scale, and to be laser focused on standardization.

In the end, the most effective partnerships share three qualities: a genuine commitment to co-creation rather than transactional relationships, complementary expertise that challenges our thinking, and a shared focus on patient impact. By combining McLaren's precision engineering, best-in-class tech standards, startups' agility, and our deep pharmaceutical expertise, we're accelerating our journey to bring life-changing treatments to patients faster than ever before.

About The Expert:

Brendan O’Callaghan is an executive vice president and head of manufacturing and supply at Sanofi where he over sees a global network of close to 40 manufacturing sites, supported by strategic external supply partners. Previously he was a vice president of EMEA operations at Merck/MSD and before that, he held leadership roles at Schering-Plough and Mallinckrodt.