Japan Food Research Laboratories

Japan Food Research Laboratories (JFRL) conducts a wide range of non-clinical studies on pharmaceutical drugs, medical devices, and chemical substances in compliance with the GLP standard.

With extensive experience and comprehensive testing facilities, the organization provides contract research services covering safety and toxicity evaluations, as well as storage stability testing, to meet diverse clients’ needs.

Features of JFRL’s Contract Services for Non-Clinical Studies

Comprehensive Toxicity Evaluation System In a Wide Range of Testing Methods

JFRL performs both in vitro and in vivo studies in compliance to GLP standards. Its capabilities include various toxicity evaluations—such as cytotoxicity, mutagenicity, and acute toxicity testing for medical devices, pharmaceutical drugs, and chemical substances. Analytical methods followed by ISO, OECD Test Guidelines, and the Japanese Pharmacopoeia, ensuring full regulatory compliance.

The laboratory also provides flexible study designs tailored to client’s requirements and applicable legal frameworks.

Testing for a Wide Variety of Materials Including Medical Devices and Chemicals

A notable strength of JFRL is its capability to conduct testing across a broad spectrum of materials and products, such as medical devices and their components, foods, pharmaceutical raw materials, and industrial chemicals. By applying multiple international and domestic standards—such as OECD TGs, Medical Device Guidance, and the Japanese Pharmacopoeia—JFRL offers customized testing strategies suited to the intended use and characteristics of each material.

Each test category clearly specifies its applicable scope and required sample quantities, allowing for efficient study planning from the beginning.

Specialized Facilities for Stability Testing

For storage stability studies, JFRL operates their specialized facilities equipped to perform long-term, accelerated, and stress-condition testing. The facilities are supported by an independent power supply and automated alert systems, ensuring prompt responses to any unusual event during the testing period.

Temperature, humidity, and light conditions can be precisely controlled to accommodate diverse storage requirements, with its integrated analytical systems in place for post-storage evaluation. This robust infrastructure enables JFRL to meet a wide range of stability assessment needs.

Example of Disease Models by JFRL

No information on disease models was found on the official website.

Case Example of JFRL’s Non-Clinical Testing

Evaluation of Genotoxicity Using the Ames Test

JFRL conducts reversion mutation tests (Ames tests) for medical devices, chemical substances, and food products.Mutagenicity is assessed following the 1999 Ministry of Health, Labour and Welfare guidelines and medical device guidance.

Tests are typically conducted using 5 g of solid samples or 10 g of liquid samples, with a standard turnaround time of approximately two months. The cost starts from 400,000 yen (excluding tax), and expedited testing is not available. This study design is particularly relevant to applications in the pharmaceutical and chemical sectors.

Reference: https://www.jfrl.or.jp/service/safetytrial

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