Shinji Fujino, Co-Founder and CEO; Yutaka Kuroda, PhD, Co-Founder and CSOUnlike traditional vaccines that rely on entire viruses or full-length viral proteins, PI-Bio focuses on specific protein domains for improved effectiveness and safety. The platform identifies stable domains, enhances its physicochemical properties and optimizes immunogenicity to create ideal vaccine antigens for targeted immune responses.
“Our technique enables modulating immunogenicity through protein engineering, offering a cost-effective, scalable solution with vast potential for global vaccine development,” says Shinji Fujino, co-founder and CEO.
PI-Bio addresses two significant challenges in protein domain vaccine production. First, it ensures proteins are expressed in their native or active form, a traditionally complex task based on protein folding. The platform has proven its capability in this, achieving results in a short timeframe. It also overcomes glycosylation concerns typically present in E. coli expression systems for all examples so far.
Research, including examples using coronavirus (COV2) as a model, has demonstrated the platform’s powerful capabilities.
Using COV2, the team zeroed in on the spike protein, a critical component in the virus’s infection process. They identified the receptor binding domain (RBD), the part of the spike protein that directly contacts host cells, and synthesized it in E.coli through advanced protein engineering. To boost its immunogenicity, they attached an SCP tag, a short peptide sequence that enhances immune response and memory. The generated anti-sera demonstrated neutralizing activity, highlighting its potential as a robust candidate for a vaccine antigen.
The platform offers several critical advantages at the development stage. As it uses only a segment of the viral protein, it enhances safety, reducing the risk of potential infections and enabling work under a much lower safety regulation level than using the whole virus. Researchers can produce RBD cost-effectively and sustainably in large quantities using E. coli expression, making the process more environmentally friendly. Further, RBD can be produced using standard equipment for any other E.coli-produced protein therapeutics, such as insulin, which can enormously lower the initial investment cost.
Our technique enables modulating immunogenicity through protein engineering, offering a cost-effective, scalable solution with vast potential for global vaccine development
In addition, the RBD is highly effective in inducing neutralizing antibodies, as it includes both an epitope for antibody recognition and a region that binds to the host cell receptor. This protein is readily freeze-dried and can also be conveniently stored as powders at 4°C for several months, avoiding the deep-freeze conditions required for mRNA vaccines. A critical advantage is its ability to adapt to viral mutations rapidly by introducing changes to the original virus sequence.
Protein Immuno-Engineering Laboratories’ involvement with pharmaceutical companies happens early in vaccine development. The team guides clients in selecting specific components that can accelerate their product lines and align with their development strategies. Once the ‘vaccine seeds’ are supplied, pharmaceutical companies can take over to conduct large-scale pre-clinical and clinical trials and engage with regulatory authorities.
The PI-Bio platform presents diverse applications that foster opportunities for collaboration with varied pharma companies. Utilizing the SCP tag and protein engineering techniques, it enables the rapid creation of subunit vaccines with improved immunogenicity. These enhanced protein sequences can allow integration into mRNA and DNA vaccines, expanding the application potential. As a by-product of subunit vaccine production, PI-Bio can also accelerate the development of monoclonal antibodies for diagnostic purposes. Further broadening the platform’s impact, its vaccine antigens are valuable tools for screening and creating adjuvants—substances that enhance the immune response— to optimize vaccine efficacy.
For companies that may independently design targets, Protein Immuno-Engineering Laboratories offers valuable services such as standardized biophysical characterization or neutralization assays in model mice, aiding the transition from sequence to protein domain vaccines.
“We prefer establishing long-term research contracts to ensure our strategies consistently and successfully support the development of their protein domain-based vaccines or related goals,” says Yutaka Kuroda, cofounder and CSO.
A startup originating from the Tokyo University of Agriculture and Technology, Protein Immuno-Engineering Laboratories continues to enhance vaccine design and production processes, positioning itself as a vital player providing innovative solutions capable of addressing public health challenges.
