LenioBio GmbH has been awarded EU4Health funding by the European Health and Digital Executive Agency (HaDEA), which implemented the corresponding call for proposals on behalf of the European Commission’s Health Emergency Preparedness and Response Authority (HERA). The project will focus on further development of the cell-free protein expression system, ALiCE®, as an innovative, rapid and on-demand medicine manufacturing technology with strategic value for Europe, fitting into the mission of HERA. The project has been awarded a grant of EUR 3.7M and commenced on 1st July 2025, continuing until late 2027.
This EU4Health action contributes to the European Union’s strategic objective to strengthen the availability, accessibility, and affordability of essential medicines. By supporting the development of innovative manufacturing processes, HERA aims to enable more efficient, cost-effective, scalable, sustainable, and environmentally cleaner production of medicines.
LenioBio will contribute with a project titled “Innovative protein medicine biomanufacturing with Continuous-Modular ALiCE“, where key goals for the project include:
- Scaling ALiCE® lysate production by optimising process yields, increasing batch size and transitioning to continuous manufacturing
- Expanding ALiCE® capabilities for targeted classes of protein medicines such as vaccines, multispecific antibodies and growth factors by engineering new functionalities and demonstrating modular protein production methods at scale
- Laying the groundwork for GMP-grade lysate production by establishing analytical qualifications, quality systems, and regulatory filing package
“This grant is another significant milestone for LenioBio. It enables us to scale our platform and broadens its application for medicine production, providing a future proof solution for the agile production of novel and complex proteins.” said André Goerke, CEO of LenioBio.
LenioBio’s project has been awarded the STEP Seal by the European Commission. The STEP Seal is granted to proposals deemed strategically important for Europe’s technological and health sovereignty (https://www.leniobio.com/press-release/leniobio-earns-prestigious-eu-step-seal-a-signal-of-excellence-for-investors/).
ALiCE® Cell-Free Protein Expression System is designed to scale seamlessly from research to production, enabling the rapid synthesis of complex proteins without relying on living cells. The platform is already supporting vaccine development and drug discovery by enabling fast, flexible protein production. With support from the EU4Health grant, LenioBio is now advancing ALiCE® to meet the demands of clinical use and large-scale manufacturing.