This collaboration is part of the expansion in scope of LenioBio's CEPI-funded project, which aims to showcase the capacity and speed of LenioBio's proprietary ALiCE® protein expression technology to accelerate production of vaccine-relevant proteins for use in clinical trials. This project fully aligns with the 100 Days Mission spearheaded by CEPI.
The project extension follows a successful first six months during which LenioBio achieved all key milestones. They successfully demonstrated ALiCE®'s ability to reliably produce vaccine-relevant proteins at small scales from cell-free DNA formats, and developed a suite of novel quality control assays to ensure the highest standards of product integrity and safety throughout the protein production process.
Building on this success, LenioBio will be collaborating with ReciBioPharm to achieve scaled production of vaccine proteins using ALiCE®. ReciBioPharm's expertise in process development and manufacturing of complex biologics, along with its global footprint, will be instrumental in unlocking the full potential of ALiCE® for vaccine manufacturing and pave the path towards future GMP applications.
"Being involved in the 100 Days Mission is both an honor and a significant responsibility," said André Goerke, CEO of LenioBio. "Our collaboration with ReciBioPharm brings us one step closer to making the vision of rapid vaccine development a reality. By transferring protein production with ALiCE® to a leading CDMO, we aim to meet the urgent need for swift vaccine production, crucial for containing emerging health threats."
The newly announced collaboration will include technology transfer for 10-liter scale protein production of a vaccine candidate, using ALiCE®- including both upstream and downstream unit operations - to ReciBiopharm' site in Oeiras, Portugal. This process will involve initial process and analytical method transfer and will deliver material to be used in pre-clinical studies. Establishing the ALiCE® technology in a scaled manufacturing environment is a critical first step in a roadmap toward GMP and the production of material for clinical trials and vaccine manufacture.
Vikas Gupta, president, ReciBioPharm, said: "Our collaboration with LenioBio represents a significant step forward in recombinant protein manufacturing. LenioBio's ALiCE® technology is well-positioned to make a meaningful impact on global health, and accelerate the development of vaccines and other critical biologics. ReciBioPharm is glad to play a crucial role in proving LenioBio's innovative platform at-scale and look forward a future where such technology will be used in clinical trials. This partnership perfectly aligns with our commitment to innovation. We are making the vision of a future where vaccines can be developed and deployed more rapidly in response to emerging threats, a reality."
Looking ahead, LenioBio plans to conduct in-depth evaluations of ALiCE®-produced protein quality through in vivo studies focusing on dosage and efficacy. The company also intends to engage in further regulatory discussions to position ALiCE® as a platform technology for expedited development of protein medicines, aiming to reduce the time it takes for vaccines and therapeutics to reach clinical trials.
About LenioBio:
LenioBio is a life sciences biotech company, pioneering a disruptive protein expression platform. Using ALiCE® technology, enabling customers – researchers and biopharma manufacturers to streamline and accelerate their protein discovery, development, and production processes. LenioBio simplifies manufacturing and speeds up the delivery of drugs to the patients.
About ReciBioPharm:
ReciBioPharm, a division of Recipharm, is a contract development and manufacturing organization (CDMO) specifically established to focus on serving companies seeking to develop and commercialize advanced therapy medicinal products (ATMPs). ReciBioPharm's specialized CDMO capabilities include pre-clinical to clinical and commercial development and manufacture for new biological modalities encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production. Led by a management team and technical experts with a proven track record in both process development and contract manufacturing, ReciBioPharm offers the knowledge and resources necessary to help customers develop and manufacture promising new therapies to meet the needs of patients across the world.
