We will conduct in vivo and in vitro tumorigenicity tests that are essential for quality control of iPS cell products and others.
- In vivo tumorigenicity test Using immunodeficient animals (NOG mice), we evaluate the tumorigenicity of the test samples during the observation period. - In vitro tumorigenicity test We culture, amplify, and observe the test samples to directly detect undifferentiated pluripotent liver cells. (Culture amplification method) We are participating in a validation project for testing methods (MEASURE) supported by AMED, conducting experimental studies on testing methods at our facility. We have a track record of long-term breeding of NOG mice and possess background data.
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Our company is located in the nature-rich city of Ina, Nagano Prefecture, surrounded by two Alps, and has been serving our customers as a non-clinical trial contract research organization (CRO) for 50 years. Since 2022, we have become a member of the Shin Nippon Science Group, expanding and enhancing our contract testing items and analyses, and we can quickly respond to the procurement of various testing materials (such as animals). Non-Clinical Trial Business We accept safety and efficacy testing for pharmaceuticals, chemicals, pesticides, food, medical devices, and more. We conduct in vivo tests using small animals, rabbits, dogs, and monkeys, as well as in vitro tests using bacteria and cells, and various alternative method tests. Additionally, we specialize in the creation of SEND data required for FDA applications for new drugs, and we also undertake work related to SEND conversion and QC for data creation and conversion only. Our facility was the first in Japan to obtain full accreditation from AAALAC International (the Association for Assessment and Accreditation of Laboratory Animal Care International), and we are committed to international standards of animal welfare. We also propose tests necessary for various applications and registrations in compliance with regulations in different countries and regions.
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