CellFree Sciences
Optimizing Innovation

The COVID-19 outbreak has created a global health crisis with a drastic impact on the socio-economic lives of people all over the world. At the forefront of early surveillance and guide to patient treatment is Diagnostic Testing. As the number of cases increases, governments and healthcare providers worldwide are exploring possibilities of addressing the chronic shortage of diagnostics and meeting the high demand for rapid assay development. One company, CellFree Sciences (CFS), focuses on enabling developers and producers of diagnostic products to drive innovation for new diagnostic solutions to meet the pressing need of the hour. With its focus on developing quality products to address unprecedented requirements in the diagnostic market— the company was founded as a spinoff venture in 2002 to commercialize the wheat germ cell-free protein expression system developed at Ehime University in Japan. CellFree Sciences’ expression system was successfully used by Prof. Akihide Ryo at the Yokohama City University School of Medicine to develop serological tests for COVID-19 that are now offered in the market by Kanto Chemical. "The timely COVID-19 tests demonstrate, our technology is well suited to support rapid development of new diagnostic tests to match the challenges for bringing better diagnostics to the people at need," explains President and CEO, Satoshi Ozawa.

By singling-out, the protein expression machinery from a living cell, experts at CFS, made it possible to do all protein expression experiments in simple in vitro assays requiring no special equipment. "CFS' protein expression technology matches with the throughput required during maker discovery—while being fully scalable to deliver the protein amounts for the production of diagnostic products," adds Ozawa. Owing to the flexibility and adaptability of the firm's cell-free protein expression system, partners and customers were able to discover and evaluate new markers applying protein panels during screening. The production of positive hits from those screens could easily be scaled to provide the necessary protein amounts for further evaluation, prototyping, and later production. These assays can be customized to individual proteins' needs as it is no longer required to consider other processes ongoing in living cells.

Furthermore, being done in vitro allows CFS to develop robotic means to scale the throughput of protein production to genome-wide studies involving thousands of proteins. Once expression conditions have been established, the company can do on-demand protein synthesis within short turnaround times.

"Our services can support all protein needs of our partners regardless if they choose to utilize a protein in a test directly or use our proteins as antigens in antibody development and testing," elaborates Ozawa. In 2017, the firm obtained ISO 9001 certification for the design, development, and manufacture of reagents for Protein Synthesis.

Our technology is well suited to support rapid development and deployment of new diagnostic tests to match the challenges for bringing better diagnostics to the people

CFS' proprietary technology has an impressive record for synthesizing proteins for individual assays or working with multiple proteins on the same platform rather than depending on cellular protein expression systems. The company has long-standing customers and partners in Asia, Europe, and the USA with leaders such as Abnova relying on its protein expression system for their research and development projects and product sales. To further illustrate, CFS' efficiency, Ozawa cites a study conducted by Prof. Ivo Mueller at the Walter and Eliza Hall Institute of Medical Research in Australia supported by Profs. Eizo Takashima and Takafumi Tsuboi at Ehime University in Japan and financed by Global Health Innovative Technology (GHIT) Fund. The international collaboration led to the identification of a panel of serological markers to indicate recent P. vivax malaria infections. The study was an important step forward because researchers for the first time detected patients with otherwise undetectable liver-stage parasites. These parasites can cause relapses of the disease without new infection by the mosquito vector. Therefore, it is crucial to identify such patients for the treatment of liver-stage parasites and better support of malaria control programs. This study benefited from making difficult-to-express malaria antigens in CFS' wheat germ cell-free system, which otherwise would have been hard to obtain in any other expression system. In addition, it proofed advantageous to express the proteins in a wheat system reducing backgrounds often seen with proteins made in bacteria.

As the pandemic continues to spread across the globe—the efforts in vaccine development and serological testing are seeing innovative approaches and new kinds of partnerships. CFS had for long supported project for serology testing, which include a protein bead array technology, called 'CF-PA2Vtech', to support discovery projects for autoantibodies that could indicate chronic diseases, including cancer, and testing of individual antibodies. While having a set of ~20,000 full-length human proteins ready for testing, CFS can extend the platform with other proteins following customer needs. The platform enables researchers to speed up tests in development phases such as the specificity of antibodies against human proteins, aid discovery of antigens or autoimmune targets. "With our formidable technologies and services, we want to be recognized as a trusted partner for the development and later production of new solutions in the diagnostic market," concludes Ozawa.