CHO-based SPEEDy CELL line development for pandemic response

The EU has faced concerns regarding the availability of medicines, with shortages becoming systemic over the past decade. These shortages impact the health of EU citizens, and the resilience of health systems. The COVID-19 pandemic has underscored the critical need for a continuous supply of medicines, revealing vulnerabilities in the pharmaceutical value chain at many levels. The European Institutions have recognized medicine shortages as a major public health concern, urging the EC and Member States to take action. The Pharmaceutical Strategy for Europe, aims to improve medicine availability, initiating the structured dialogue on security of medicines supply. In response to the pandemic and other health threats, the EC established the HERA to enhance the EU's crisis preparedness. HERA identified flexible, multi-technology manufacturing and process innovation to improve access to critical medical countermeasures, as a main topic. The SPEEDCELL project, aligns with these goals by developing an innovative process for manufacturing vaccines and therapeutics (mAbs). SPEEDCELL aims to transform CHO-based production into a faster, more reliable platform, addressing the long development times of current strategies. By optimizing development and manufacturing processes, SPEEDCELL seeks to enhance efficiency, reduce costs, and ensure high product quality. The project aims to achieve the '100 Days goal,' revolutionizing the development and distribution of vaccines and mAbs during health crises. SPEEDCELL targets two strategic needs: boosting manufacturing capacity for critical medicines and promoting innovation in therapeutics and vaccine production. The project's general objective is to expedite Cell Line Development and optimize manufacturing processes for vaccines and therapeutics, ensuring quality, scalability, and sustainability. This will enhance the EU's capacity to respond to health emergencies, ensure regulatory compliance, and facilitate market introduction.