Takara Bio Inc.

Takara Bio Inc. serves as the point of contact for services provided by Mediford Corporation, such as GLP-compliant safety testing for nonclinical studies, with extensive experience across study types. This section outlines the characteristics of Takara Bio’s nonclinical services, provides an example of a disease model, and summarizes representative case studies. Please use this information as a reference when selecting a provider to conduct nonclinical studies.

Nonclinical Studies Undertaken by Takara Bio Inc.

GLP-compliant safety testing system specialized for regenerative medicine products

In the development of regenerative medicine and gene therapy products, the company provides high-quality GLP-compliant safety testing and is capable of conducting the range of studies required for regulatory submissions, including repeated-dose toxicity studies, tumorigenicity studies, and soft agar colony formation assays. A team that includes pathologists certified by JSTP and JCVP, veterinarians, pharmacists, and toxicologists certified by JSOT is in place to deliver reliable data efficiently.

Efficacy and kinetic evaluations using disease models and advanced analytical methods

Efficacy evaluations are performed using immunocompetent and immunodeficient animal models, and pharmacokinetic and biodistribution assessments leverage advanced technologies such as qPCR, ddPCR, and IVIS (In-Vivo Imaging System). These methods enable high-sensitivity, quantitative analysis of the in-vivo biodistribution and persistence of administered cells and viral vectors. Evaluation strategies are tailored to the characteristics of each regenerative medicine product, with coordinated support from research and development through clinical application.

End-to-End Service Integrated with Manufacturing and Quality Testing

Centered on the Center for Gene and Cell Processing (CGCP), the company provides integrated nonclinical testing services together with manufacturing and quality testing for biopharmaceuticals and regenerative medicine products. End-to-end support spans the full development process, including cell bank and viral vector production, quality testing (e.g., sterility, mycoplasma, endotoxin), characterization, and regulatory submission support—helping to shorten development timelines while maintaining quality.

Contract Companies Supported by Takara Bio Inc.

Mediford Corporation

Mediford Corporation offers a broad portfolio spanning safety studies for regulatory submissions, pharmacology/efficacy studies, and pharmacokinetic studies. The organization is staffed by specialists—such as pathologists certified by JSTP and JCVP, veterinarians, pharmacists, laboratory animal technicians, and toxicologists certified by JSOT—who provide contract services across diverse study types.

Takara Bio Inc. Nonclinical Case Studies

Single-Dose Toxicity Studies

Single-dose toxicity studies are performed in mice and rats via various routes of administration. Test items include those aligned with the contents of guideline-based repeated-dose toxicity studies, safety pharmacology core battery tests, and local tolerance (local irritation) tests. Toxicokinetic (TK) assessments can be paired with immunostaining and PCR.

In Vitro Tumorigenicity (Soft Agar Colony Formation Assay)

The soft agar colony formation assay is used to evaluate tumorigenic potential in vitro. The offering features three in-vitro tumorigenicity assay formats: conventional soft agar, fluorescence-based soft agar, and digital soft agar colony formation assays.

Company Information of Takara Bio Inc.

Takara Bio Inc. supports from research and development to clinical application by utilizing the technology and know-how of gene therapy and cell medicine, on which the company has been cultivated over the years.