Source: Bioprocessing Summit (Boston, August 20, 2025)
Harnessing Data and AI to Transform Bioprocessing
At this year’s Bioprocessing Summit in Boston, Cenk Undey, PhD—recently appointed iCMC Digital Transformation Program Lead at Sanofi—urged the industry to look “beyond digital” toward a future where data, artificial intelligence (AI), and automation fundamentally reshape how biologics are developed and manufactured.
To make his point, Undey recalled a childhood moment on Turkey’s Gökçeada island: once he could see under the water with old swimming goggles, fishing became predictive instead of guesswork. That’s the power of AI in bioprocessing—shifting from intuition to informed prediction.
From Biotech 3.0 to Bioprocessing 4.0
The sector is moving beyond the 2010s wave of new modalities (Biotech 3.0) into Bioprocessing 4.0, where machine learning, advanced analytics, and automation compress timelines, improve outcomes, and reduce costs.
- Image analysis at scale: Deep learning cut cellular image review from ~40 hours to ~3 at Amgen.
- Smarter runs: ML-driven feeding strategies improved cell growth and titers in smart manufacturing pilots.
- Targeted experiments: In silico modeling shortened a formulation robustness study by 24 days.
Undey’s caution: don’t chase “fancy” tools unless they’re scalable and can be adopted broadly.
Sanofi’s iLab Journey
Launched in 2020, Sanofi’s iLab has scaled to 2,500+ users across 100 labs and 20 sites spanning biologics, synthetics, and vaccines. The program integrates process modeling, generative AI, robotics, and automation under a unified digital transformation strategy.
Still, technology isn’t enough. Success depends on people and roles: upskilling and reskilling require intentional investment, not passive expectation.
Toward Self-Optimizing Labs
The vision is a self-optimizing ecosystem: moving from reactive to proactive—and ultimately anticipatory—operations, much like autonomous driving. The payoff includes faster development, lower costs, greener footprints, and higher quality.
As Undey framed it, the question isn’t whether we can “catch more fish,” but how quickly we can help the entire community see beneath the surface.