Are-You-Ready-For-Digital-Bioprocessing

A panel discussion at the Danaher Summit 2026 on The Next Era of Bioprocessing, featuring Andrew Heron (CEO of Portal Biotech) and Michelangelo Canzaneri (Merck KGaA) exploring why digital bioprocessing has underdelivered despite a decade of promises. The panelists identify the foundational gap — IT/OT convergence, data quality, and ontology building — as the real blocker, not AI capability itself. Merck's real-world deployments are cited throughout, including a 50% reduction in CMC experimentation via digital twins and predictive maintenance that identifies failures 2 weeks in advance. The session concludes with a 2031 vision of smart factories measuring molecular outputs in real time, enabled by federated AI learning and industry-wide data standards.

Key Takeaways

The industry misperception is that digital bioprocessing means applying AI directly to current environments; the real foundation is IT/OT convergence and building data infrastructure, ontologies, and knowledge graphs before AI can generate value.
Merck KGaA achieved a 50% reduction in per-molecule CMC experimentation by deploying digital twins after first building foundational data layers and ontologies in collaboration with external industry consortia.
Merck's predictive maintenance AI identifies equipment failures 2 weeks in advance; performance improved further through cross-industry sharing of non-sensitive equipment data, reducing failure modes to near zero.
Module Type Package (MTP) reduces equipment integration time from 9 months to 2 days, but broad adoption is stalled by lack of collective industry agreement on shared ontologies and standards.
Fully implemented digital bioprocessing is predicted to compress time-to-market by at least 3x, reduce costs, and improve sustainability — with competitive advantage rooted in modular, scalable data architectures.
CDMOs currently trapped in Excel-based data workflows reinvent processes for each molecule; federated AI learning with secure data sharing is the proposed path to building persistent, improving bioprocessing models.
The 2031 winning vision is a smart factory that measures molecular outputs in real time and uses quality-by-design to implement CMC in under a year for any new modality.