To accelerate the development and production of biologics, enabling a swift response to health emergencies, aligned with the EU’s “100 Days Mission”
The project aligns with European strategies to strengthen health security and address systemic medicine shortages, particularly in the context of health crises and pandemics.
objectives
Optimize cell line development
To drastically shorten development timelines for biological medicines, especially vaccines and monoclonal antibodies.
Shorten timelines for biologics manufacturing
To establish a robust, rapid, and scalable cell-based manufacturing platform capable of responding to future pandemics.
Increase flexibility and scalability in production
To meet the “100 Days Mission”: ensuring that, in the event of a public health emergency, new vaccines and therapeutics can be developed and produced within 100 days.
Strengthen EU medicine supply resilience
To improve supply chain resilience and reduce dependence on external production capabilities, in line with the Pharmaceutical Strategy for Europe.
mission
SPEEDCELL’s mission is to boost Europe’s ability to respond to health emergencies by streamlining cell line development and manufacturing. By fostering innovation and flexibility, the project enables the rapid production of affordable, high-quality biologies, in line with HERA’s goals for improved access to essential medical countermeasures.
Project leader
The project is being developed entirely in Spain and strengthens the country’s role as a strategic player in biopharmaceutical innovation and European health preparedness.
Working packages
Project Management and Coordination
WP1 will ensure the correct implementation of the project, maintaining alignment with its scientific, technological, and strategic goals.
Development of a gene synthesis platform
WP2 will develop a fully integrated in-house gene synthesis platform that drastically shortens the development timelines for biological products.
Cell-expression platform development focused on speed
WP3 will develop a fully integrated in-house gene synthesis platform that drastically WP3 aims to accelerate and streamline biopharmaceutical development by introducing novel and efficient strategies for plasmid engineering.shortens the development timelines for biological products.
Cell line and process development streamlining
WP4 will focus on optimizing and accelerating Cell Line Development (CLD) workflows through advanced technologies and integrated processes. To further streamline operations, Upstream Process (USP) development activities are embedded directly within the CLD workflow and conducted in parallel with seed lot system preparation.
Speedy cGMP-compliant and representative active substance from stable pools, and design of emergency preclinical programs
WP5 aims to drastically reduce development timelines by establishing strategies for producing representative active substances from stable pools within a targeted timeframe of under 30 days from sequence to purified active substances. To support rapid response capabilities, an accelerated preclinical framework will be established as a reference model for health emergencies.
Platform assembly and Pilot trials
WP6 involves assembling a comprehensive and modular CLD platform that integrates all critical stages. The platform’s operational readiness will be rigorously tested through pilot trials simulating emergency conditions.
Regulatory compliance
WP7 will ensure that all newly developed technologies and processes are fully compliant with current regulatory standards, enabling their immediate application in real-world scenarios and securing endorsement from leading regulatory bodies.
Business, Sustainability and Intellectual Property Rights (IPR)
WP8 will ensure the long-term exploitation and impact of SPEEDCELL’s results through the development of a comprehensive business plan.
Communication & Dissemination
WP9 will communicate the state and results of the SPEEDCELL project. It will also participate in major European and international events and conferences to increase visibility and awareness of the present project, and will establish contact and collaborate with related EU initiatives and agencies related with the approval of the manufacturing process.
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Accelerate the development and production of biologics
Funded by the European Union under grant agreement No 101136439. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union (EU) or European Health and Digital Executive Agency (HaDEA). Neither the EU nor HaDEA can be held responsible for them.