News
Chiyoda Corporation and Tokyo Ohka Kogyo Sign an MOU to Jointly Commercialize the TOK Microphysiological System 'Fluid3D-X®'
Chiyoda Corporation (Chiyoda) and Tokyo Ohka Kogyo Co., Ltd. (TOK) have signed a Memorandum of Understanding (MOU) for the joint marketing and sales of 'Fluid3D-X®', a microphysiological system (MPS).
Background and Objectives
Pharmacokinetics, safety and efficacy of candidate substances have traditionally been evaluated through animal studies using mice, primates and other laboratory animals in the development of substances intended for use by humans. Particularly in the development of pharmaceuticals, stringent assessment of potential toxicity is required before initiating human clinical trials and such assessments have conventionally included studies using larger animals, such as primates.
In recent years however, new modalities such as gene therapies, nucleic acid therapeutics and cell-based therapies have been developed at an accelerating pace and conventional evaluation methods may not always adequately predict the efficacy and safety of these emerging modalities. Amid the global trend towards reducing the use of animals in research and development, New Approach Methodologies (NAMs) are attracting increasing worldwide attention.
MPS is recognized as a NAM and represents an advanced evaluation approach using human organ-derived cells incorporated into microfluidic devices, and other platforms, to reproduce aspects of the physiological environment in the human body and predict organ-level responses. MPS therefore offers a promising approach to addressing the limitations of conventional evaluation methods.
MPS platforms consist of devices and mechanisms incorporating microfluidic channels and other structures required for cell culture. Their development and practical application require hardware expertise, including advanced materials processing technologies, and expertise in the culture of cell types and the establishment of assay systems for efficacy and safety evaluation.
TOK is a leading manufacturer of photoresists, one of the fundamental technologies enabling the continued miniaturization and advancement of semiconductor devices. Chiyoda possesses expertise in Contract Research and Development Organization (CRDO)*1 services utilizing cells and engineering and design expertise based on regulatory requirements applicable to pharmaceutical manufacturing facilities. TOK and Chiyoda have therefore signed an MOU to jointly market and sell 'Fluid3D-X®', an MPS device manufactured by TOK.
Outlook
Chiyoda and TOK will provide the Fluid3D-X® system and a range of implementation support services, including training and demonstrations during system introduction, to customers seeking to utilize MPS technologies, including ongoing technical support following implementation.
Although further technological advancements in MPS are anticipated, products manufactured outside Japan currently account for a significant portion of the MPS market. Chiyoda and TOK will initially focus on meeting Japanese customer demand by forging long-term customer relationships, incorporating feedback from users of Fluid3D-X® and continuously improving products and services offered.
Chiyoda and TOK will continue to leverage the networks and capabilities of both companies and collaboratively promote technologies and products originating in Japan, thereby contributing to the advancement of research and development in the pharmaceutical and life sciences sectors.
Chiyoda and TOK Initiatives
Chiyoda is accelerating its initiatives in the field of regenerative medicine under its purpose of 'Enriching Society through Engineering Value'.
Chiyoda established a cell processing facility (TACT*2) within the University of Tsukuba Hospital in 2025 and established a three-site collaboration network comprising TACT, the University of Tsukuba and Chiyoda's Shin-Koyasu Laboratory. Chiyoda has launched full-scale collaborative CRDO services using this network to provide seamless support to co-creation partners across the entire development process, from basic research and development through to manufacturing process development.
TOK has been developing and commercializing Fluid3D-X®, an MPS device made from non-PDMS*3 materials.
Fluid3D-X® combines a cell culture chip with a perfusion culture system to reproduce a microenvironment more closely mimicking physiological conditions in the human body, facilitating applications in pharmacokinetic, safety and efficacy assessments.
TOK is collaborating with pharmaceutical companies and universities to establish evaluation and assay systems, provide implementation training, develop procedures for Installation Qualification (IQ) and Operational Qualification (OQ) and develop a comprehensive technical support framework for the practical adoption of MPS and expand their use in drug discovery research.
TOK is also participating in international standardization activities related to MPS within the International Organization for Standardization (ISO) and, by promoting standardization in areas such as MPS device fabrication technologies and quality assessment, is working to accelerate the practical implementation and broader adoption of MPS technologies.
Notes
- CRDO: Contract Research and Development Organization provides outsourced services covering pharmaceutical and regenerative medicine product activities from research through development.
- TACT: Tsukuba Advanced Cell Therapy facility, a cell processing facility established by Chiyoda at the University of Tsukuba.
- PDMS: Polydimethylsiloxane, a silicone-based polymer.
For further information, please contact:
Chiyoda Corporation
PR & Sustainability Advanced Section
Email: chiyoda_pr@chiyodacorp.com
URL: https://www.chiyodacorp.com/en/contact/index.php