Digitalization of biDigitalisation of biomanufacturing is key to increasing efficiency, reducing costs, and ensuring quality control in the production of biopharmaceuticals and advanced therapies. Dig4Bio aims to: i) advance the research capacity and profile of the coordinator IST (PT) in the field of digitalisation of biomanufacturing, and ii) strengthen the research management and administrative skills of IST. This will be achieved through a strategic alliance with experts in digital biotechnology from PROSYS, DTU (Chemical and Biochemical Engineering, DK) and lab automation TU Berlin (Chair of Bioprocess Engineering DE). Dig4Bio includes 6 Work Packages (WPs). WP1 (Advancing scientific capacity) and WP2 (Enhancing research management capacity) focus on stepping up the scientific and research management skills of IST through tailored training (workshops, training schools, digital tools, short term visits). In WP3 (Joint research activities), Dig4Bio partners will collaborate on a pioneering R&I initiative that addresses the question: “How to develop and incorporate a digitalisation framework in the conceptual design, research and development of biomanufacturing processes”. Attention is focused on Escherichia coli-based manufacturing of plasmid DNA, a biomolecule that is gaining increased relevance as a biological (e.g. DNA vaccination, in vivo gene therapy), and as a raw material in the manufacturing of gene/cell therapies (e.g. mRNA vaccines). WP4 (Clustering Activities) aims to foster close ties, synergies and knowledge exchange between the consortium and stakeholders, whereas WP5 (Communication and Dissemination) aims to disseminate findings and promote awareness of the field. WP6 (Coordination and Management) provides the necessary administrative support to ensure the successful and timely execution of all project components. The expected outcomes for Dig4Bio include the elevation of IST profile in digitalisation of biomanufacturing and in research management.

Reducing lead times of new medicinal drugs to the market by reducing process development and clinical testing timeframes is a critical driver in increasing European (bio)pharmaceutical industry competitiveness. Despite new therapeutic principles (e.g. the use of pluripotent stem cells, regenerative medicine and treatments based on personalised medicine or biosimilars) or regulatory initiatives to enable more efficient production, such as Quality by design (QbD) with associated Process Analytical Technology (PAT) tools , the slow progress in the development of new bioactive compounds still limits the availability of cheap and effective medicines. In addition, the competitiveness of European (bio)pharma industry is impacted by the unavailability of suitably trained personnel. Fundamental changes in the education of scientists have to be realised to address the need for changes in the traditional ‘big pharma’ business model and the focus on ‘translational medicine – more early stage clinical trials with patients, more external innovation and more collaboration’ . These changes in education should be based on combining cutting-edge science from the early stage of product development through to manufacturing with innovation and entrepreneurship as an integral part of the training. The Rapid Bioprocess Development ITN, employing 15 ESRs, brings together industrialist and academic experts with its main aim to address this critical need by developing an effective training framework in rapid development of novel bioactive molecules from the very early stages of potency and efficacy testing to the biomanufacturing process characterisation and effective monitoring. The main focus of the research is on oncology related proteins and recombinant proteins to be used in diabetes treatment, although the resulting monitoring and modelling methods will be applicable to other bioactive molecule process development as demonstrated by validation on a range of relevant bioactives.