Four Core Technologies

There are many steps involved in the production and medical use of exosomes (EVs). We have developed unique core technologies at each step to establish a high-quality, scalable EV production platform.

①Activation Technology to produce Prime-EV^®

When cells are activated (primed) with specific stimuli during cell culture, the medicinal components (proteins and nucleic acids) of EVs produced by the cells can be enhanced. However, it is not easy to determine the optimum stimulation conditions for cultured cells according to the therapeutic purpose. After years of effort, we have developed a cell activation technology that stably produces EVs with high therapeutic efficacy by narrowing down the cell stimulation conditions while checking the titer of EVs and the content of medicinal markers using our proprietary analysis technology (4). This enables us to supply EV formulations with secured medicinal efficacy throughout scale-up and commercial production. We call the native EVs produced by this cell activation technology "Prime-EV^®. (Patent pending*1)

② Modification technology to produce "Smart-EV"

By genetically modifying the cells that produce EVs, various molecules such as antigens and nucleic acids can be loaded onto EVs. Such modified EVs are expected to be applied as DDS for vaccines and nucleic acid drugs.
In collaboration with Associate Professor Ryosuke Kojima of the University of Tokyo Graduate School of Medicine, who is a leader in EV modification research, and Professor Ken Ishii of the University of Tokyo Institute of Medical Science, who is a world-class scientist in vaccine science, we have been developing a new type of modified EV "Smart-EV™" that has novel therapeutic effects against specific diseases by carrying molecules of interest. The research is based on Professor Ishii's invention*2 for loading antigens onto EVs and Associate Professor Kojima's EXOtic device technology*3 for loading nucleic acids (mRNA) and transporting them into the target cells. Smart-EV™ is expected to develop as a next-generation DDS that can be widely applied to cancer therapy, nucleic acid medicine, gene therapy, etc.

③ INPACT-EV^® technology for high-yield purification without loss of EV activity

Cell culture supernatants contain various components other than EVs, some of which are harmful or inhibit the efficacy of EVs. Therefore, it is important to purify EVs to a high purity, but care must be taken to ensure that the activity of EVs is not compromised. We have evaluated a number of ultrafiltration membranes and separation columns commonly used in biopharmaceutical production and established a purification technology, INPACT-EV^®, optimized for EV production. The INPACT-EV^® system is automatically controlled by software and can purify a large amount of EVs from culture supernatants with high recovery efficiency without damaging the EVs physically or chemically.

④ EV-QUEST™, an EV analysis technology

We have developed a proprietary analytical technology to quantitatively evaluate whether purified EVs exhibit medicinal effects suitable for the intended use. The core of this technology is a cell-based assay that measures the potency of EVs according to their mechanism of action, and a series of analytical methods that identify a group of marker molecules associated with the drug effect and quantify each molecule. These analytical techniques can ensure reproducibility of drug efficacy in the non-clinical and clinical trial phases. The technological development of (1), (2), and (3) are supported by these analytical technologies.

Research Environment

In-house Lab

Our company is located in the Inspired. Lab, an innovation space in the heart of Tokyo. This unique environment allows us to interact with other companies and academia, fostering opportunities for groundbreaking innovations.

Our state-of-the-art wet lab is equipped to conduct cell culture, BSL2 experiments, exosome purification, and analysis. Our prime location, directly connected to the Otemachi subway station, enables us to efficiently utilize nearby medical universities' facilities and equipment, enhancing our productivity and cost-effectiveness.

In January 2024, we launched a cleanroom for exosome production. We are currently collaborating with an experienced biopharmaceutical contract manufacturing organization (CDMO) to establish cGMP for Phase1/2 clinical trials.

Research Team

Our team comprises experienced researchers from pharmaceutical companies, working together to achieve common goals. We collaborate with top academic researchers in basic and clinical fields to enhance our research productivity and provide skill development opportunities for our in-house researchers.

Compliance

We are committed to conducting research and development that adheres to the highest scientific and ethical standards. Our Research Ethics Review Committee and Recombinant DNA Experiment Safety Committee ensure compliance with laws, guidelines, and internal regulations.

We have established "Research Ethics Regulations" and mandatory training to guide our employees in conducting research activities with integrity. Our management team fosters a corporate culture that encourages open, evidence-based discussions and ensures the psychological safety of our employees.