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| ＜L-03＞：Life Science, Pharmaceutical Sciences |  |
A Platform Technology to Accelerate Biopharmaceutical Development
― Toward Integrated Development of Protein Therapeutics, Production Cell Lines, and Bioprocesses ―
| Masayoshi Onitsuka | Associate Professor |
| Applied Bioscience, Bioengineering, Division of Bioscience and Bioindustry, Graduate School of Technology, Industrial and Social Sciences | |
| Keywords | Antibody therapeutics, protein production, animal cell line development, bioprocessing |
| Laboratory URL | https://www.bb.tokushima-u.ac.jp/graduate-school/ https://researchmap.jp/biologics_onitsuka |
| Research Overview | |||
| ● High Prices of Protein Drugs, Including Antibodies, Driven by Production Costs Biopharmaceuticals, including monoclonal antibodies, offer advantages over small-molecule drugs, such as higher safety, fewer side effects, and superior therapeutic efficacy. Due to their complex molecular structures, these biologics are developed and manufactured using bioprocesses involving animal cells rather than chemical synthesis. However, their extremely high production costs remain a major challenge, ultimately resulting in high drug prices. ● Strengthening Integrated Platform Technologies to Reduce Production Costs To make antibody therapeutics accessible to a larger number of patients, it is essential to reduce development and production costs. This requires improving the efficiency and functionality of platform technologies involved in biopharmaceutical development and manufacturing. Our research team is advancing a comprehensive suite of platform technologies, including rapid expression systems for evaluating the developability and manufacturability of antibodies and protein therapeutics, cell line development incorporating genes that enhance protein production (high-functionality factors), and bioprocess development. These technologies together constitute a highly original and integrated platform. |
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| Potential Applications and Commercialization Prospects | |||
| ● Rapid Protein Expression × High-Functionality Factors = High-Performance Cell Line Development Using our proprietary protein expression technologies, it is possible to select antibodies with superior molecular properties, such as high biological activity and stability. In addition, recombinant proteins for pharmaceutical development can be produced at low cost. When introducing selected antibody genes into animal cells, the use of platform cell lines pre-equipped with high-functionality factors enables the efficient development of high-performance production cell lines. 
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| Patents | ● Japanese Patent Publication No. 2024-110946 “GENETICALLY MODIFIED CHO CELL” ● WO/2024-147331 “NUCLEIC ACID FOR ENHANCING PROTEIN EXPRESSIO” |
| Publications | ● Masayoshi Onitsuka, Norichika Ogata, Koji Tajino, “Challenges in the ‘Rational’ Construction of Antibody-Producing CHO Cells,” Journal of Bioscience and Bioengineering, Vol. 97, No. 6, pp. 331–334 (June 2019). ● Research Feature Article: “Toward the Creation of Highly Functional CHO Cells: Establishment of Methods for Gene Discovery and Introduction,” AMED pamphlet 25 Drug Discovery Technologies in Which Japan Leads the World. |
Last updated date：October 15, 2026
| Simple Inquiry | Technical consultation | Academic guidance system | Joint research/commissioned research |
