Intelligent Biomanufacturing Systems: From Design to Control in Industry 4.0

Industry 4.0 is redefining the foundations of manufacturing, yet biopharmaceutical production remains one of the least digitally transformed industrial sectors. Despite major advances in artificial intelligence, mechanistic modeling, and data infrastructure, the industry continues to operate largely in conservative, segmented workflows where design, control, and manufacturing are only weakly connected. This talk challenges that status quo and argues for a shift toward truly intelligent biomanufacturing systems, where process design, modeling, and control are unified within a continuous digital framework. At the core of this transformation lies the integration of first-principles understanding with modern data-driven approaches, enabling predictive and adaptive decision-making across the entire product lifecycle. However, the path to Industry 4.0 in biomanufacturing is not blocked by technology availability, but by risk aversion, regulatory complexity, and the high perceived cost of failure. As a result, progress toward closed-loop, autonomous manufacturing is inherently incremental rather than disruptive.

This presentation explores how hybrid modeling, digital twins, and advanced control strategies can bridge this gap, enabling stepwise but sustained transformation. It argues that the future of biomanufacturing will not be defined by a single leap to autonomy, but by a deliberate re-engineering of how data, models, and decisions interact—ultimately reshaping how biological products are developed and manufactured.

Presented by Irina Ramos, PhD, Senior Distinguished Scientist, CMC and Innovation Lead at J&J Innovative Medicine

Irina is currently a CMC project lead and an innovation lead at Johnson and Johnson Innovative Medicine organization. She works across functions and sites to facilitate the intersection between technology development and innovation applications into portfolio programs. Irina Ramos has been a key driver of the technology development and implementation strategy for continuous biomanufacturing. At AstraZeneca, with her team, she has worked to increase fundamental understanding of the various downstream unit operations of drug substance manufacturing, managing the design, testing and qualification of process equipment and automation on the systems to integrate them. Irina holds a BS/MS in Chemical Engineering from University of Porto (Portugal) and a PhD in Chemical & Biochemical Engineering from University of Maryland, Baltimore County (UMBC). For the past 15+ years, Irina’s work in the pharmaceutical industry has spanned from early to late-stage process development and validation, process scalability, CMC and technology transfer to both clinical and commercial manufacturing. With that experience, Irina lead process transfer efforts of the AZ COVID-19 vaccine. She has been involved with NIIMBL consortium since 2020, in particular with the Process Intensification program by leading the Control Strategy workstream). Irina has been teaching a graduate level class on Biotechnology Master program since 2015 about bioprocess and CMC regulatory considerations. She is passionate about mentorship and developing resources to improve the communication of science.

Presented by Dr. Tiago Matos, Assistant Professor Tecnico, University of Lisbon

Dr. Tiago Matos is a bioprocess scientist with over a decade of experience spanning academia and the biopharmaceutical industry, with a strong track record in advancing process development and industrialization strategies. He obtained his PhD from Lund University in 2014 and completed an industrial postdoctoral fellowship at Rensselaer Polytechnic Institute (2015–2016). His academic training in biochemistry and biochemical engineering underpins a mechanistic and systems-level approach to bioprocess design, with a particular focus on integrating molecular understanding into scalable and controllable manufacturing solutions. Dr. Matos has held significant roles at Novo Nordisk and MSD (Merck Sharp & Dohme), where he contributed to the development, optimization, and commercialization of biopharmaceutical manufacturing processes. His expertise spans various modalities, including nucleic acids, enzymes, antibodies, and vaccines. His work consistently focused on high-impact unit operations and the implementation of innovative technologies to enhance process robustness and efficiency. He is currently a Professor of Digital Bioengineering at Instituto Superior Técnico, University of Lisbon, where he leads research and education at the interface of bioprocess science and digital transformation. His work bridges advanced process modeling, digital twins, and smart manufacturing with the training of the next generation of scientists and engineers, fostering the integration of data-driven approaches into biomanufacturing while maintaining strong industrial relevance.

Followed by a live question and answer session