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 takes an honest look at those uncertainties, with three Horizon Europe projects contributing to its findings: Bioindustry 4.0, in which Biofaction is involved, as well as BIOS and BioSensei . Drawing on workshops, surveys, and interviews with 132 participants across the three projects’ 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, the authors 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.
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