Researchers at LenioBio GmbH (LenioBio), a biotech company based in Düsseldorf, have received CEPI funding of up to US $2 million to provide preclinical proof-of-concept that their commercially available, plant-based, and cell-free technology can produce proteins for use in clinical trials testing vaccines against epidemic and pandemic threats in 20-40 days. This is approximately a quarter of the time it takes to manufacture vaccine proteins using more traditional methods, such as cell cultures.

The technology known as ALiCE®—which stands for Almost Living Cell-Free Expression—uses the protein production machinery of plant cells, like enzymes and other biological components, to rapidly express proteins in a so-called ‘cell-free’ reaction. ALiCE® already has a proven track-record of producing various types of proteins for the development of vaccines and other medicines, including a range of viral antigens, antibody formats and membrane proteins. CEPI’s funding will support further testing of the technology to investigate its potential to enable the rapid manufacture of vaccine clinical trial material.

ALiCE®’s speed may therefore support the 100 Days Mission, a goal created by CEPI and embraced by the G7 and G20, to develop vaccines against novel pathogens within 100 days of virus identification and give the world a fighting shot at stopping the next pandemic in its tracks.

“LenioBio’s technology may be a game-changer when quickly responding to future outbreaks,” explains Ingrid Kromann, CEPI’s Acting Executive Director, Manufacturing and Supply Chain. “This study will explore whether ALiCE® can support the rapid and scalable development of viable protein-based vaccine candidates and move these promising candidates more quickly into clinical trials, pushing forward our goal to achieve the 100 Days Mission.”

With its ease-of-use, ALiCE® could be rolled out for use in remote areas or low-resource settings to help bring vaccines closer to those who need them most. The technology may also help reduce the carbon emission levels associated with traditional methods of vaccine manufacturing and distribution due to its small operational footprint.

“Embarking on this collaborative study with CEPI provides us with a great opportunity to demonstrate the significant potential of our ALiCE® protein production platform,” said LenioBio’s CEO, André Goerke. “This project supports our goals of enabling accelerated discovery and development of essential medicines, and brings us a step closer to our long-term vision of creating fast access of essential medicines for patients.

New vaccine proteins

First developed in the 1980s with the launch of a Hepatitis B vaccine , protein-based vaccines are a tried and tested type of vaccine with an established safety profile. The technology, which is also the basis for several licensed COVID-19 vaccines in use worldwide, contain harmless viral proteins known as antigens which stimulate an immune response when injected.

Typically, these protein fragments are produced using ‘whole’ cells (in vivo technique). However, cell-free protein expression systems, like LenioBio’s ALiCE® technology, instead use components extracted from within these cells to manufacture the proteins. Cell-free systems offer more rapid protein production times than in vivo techniques which require cell-line development for every protein and massive volumes of slow-growing and resource-demanding cell cultures, or extensive protein purification.

Preparing for future threats

CEPI’s investment in LenioBio’s ALiCE® technology is the latest partnership from its programme to optimise and use innovations in manufacturing processes for rapid production and scaling up of vaccines, in support of the 100 Days Mission.

CEPI and LenioBio are committed to enabling equitable access to the outputs of their partnership, in line with CEPI’s Equitable Access Policy. This ultimately includes commitment to vaccines being available first to populations at risk when and where they are needed at an affordable price should a related vaccine be developed further using CEPI funding. Relevant project results including data generated as part of this project will be published open access for the benefit of the global scientific community.