Smart biomanufacturing is no longer a future concept, it is now actively reshaping how biological processes are designed, monitored, and scaled. The fusion of automation, digitalisation, and biotechnology promises faster innovation, cleaner production, and more sustainable outcomes. But as this transformation accelerates, so do the uncertainties that come with it.
What do you see as the biggest barrier to responsible digitalisation in biomanufacturing?
A new open-access publication in New Biotechnology (Müller et al., 2026) takes an honest look at those uncertainties, and Bioindustry 4.0 is proud to have contributed to its findings alongside EU projects BIOS and BioSensei. Drawing on workshops, surveys, and interviews with 132 participants across the three Horizon Europe consortia, the study delivers the first comprehensive, participatory scan of smart biomanufacturing challenges. The challenges identified are both technical and non-technical, and neither isolated nor project-specific, but in fact structural.
In response, Müller et al. call for an expanded Safe-and-Sustainable-by-Design approach that explicitly incorporates data integrity, cybersecurity, system resilience, and human oversight alongside biological and environmental considerations. In line with the principles of Industry 5.0, smart biomanufacturing must be guided by human-centricity and sustainability, not efficiency alone.
Bioindustry 4.0 remains committed to that work, by building the shared digital services and research infrastructure that make responsible smart biomanufacturing possible.
Read the whole publication:
Müller, A., Robaey, Z., Youssef, S., Martins dos Santos, V.A.P., & Asin-Garcia, E. (2026). Digitalisation and automation in smart biomanufacturing: uncertainties, challenges and early pathways towards safe and sustainable design. New Biotechnology, 93, 378–391. https://doi.org/10.1016/j.nbt.2026.04.007