ユーロフィン分析科学研究所 List of Products and Services

Our company is capable of conducting screening analysis of elemental impurities based on the ICH-Q3D guidelines, as well as the development, validation, and testing of quantitative methods or limit test methods, using analytical instruments managed in compliance with GMP regulations. 【Features】 ■ Development, validation, and testing based on years of proven experience, ensuring optimal testing methods ■ High sensitivity and reliability in analysis using GMP-compliant ICP-MS For more detailed information, please refer to the "Related Links."

• Other contract services

Our company is capable of conducting quality testing for gene therapy products (virus vector-related) using analysis equipment managed in compliance with GMP regulations. We provide quality testing services based on the guidelines for virus vector-related products, specifically "Guidelines for Ensuring the Quality and Safety of Gene Therapy Products," Chapter 3 Quality, Section 4. Characterization and Standards and Testing Methods. The target samples include in vivo gene therapy products and in vivo virus therapy products. 【Features】 - Comprehensive support for virus vector-related quality testing - Equipped with a biosafety room (BSL-2/P2 compliant), capable of handling a wide range of virus vector types - Possession of analysis equipment managed in compliance with GMP regulations For more detailed information, please refer to the "Related Links."

• Other analysis and evaluation services

Our company is capable of developing test methods, validation, quantitative testing, or limit testing for nitrosamines analysis using analysis equipment managed in compliance with GMP regulations. Additionally, through our group's overseas laboratories, we can conduct a wide range of screening analyses for various nitrosamines. 【Features】 - High-sensitivity, high-precision, and high-resolution analysis using GMP-compliant LC-HRMS. - A wide range of screening analyses for various nitrosamines available through overseas laboratories. 【Examples of nitrosamines analyzed】 - NDMA: N-Nitrosodimethylamine - NDEA: N-Nitrosodiethylamine - NMBA: N-Nitroso-N-Methyl-4-Aminobutyric Acid - NDBA: N-Nitrosodi-n-butylamine - NEIPA: N-Nitrosoethylisopropylamine - NDIPA: N-Nitrosodiisopropylamine For more detailed information, please refer to the "Related Links."

• Other analysis and evaluation services

Our company can conduct characterization analysis of biopharmaceuticals using analytical instruments managed in compliance with GMP regulations. We provide characterization analysis services based on the ICH-Q6B guidelines, "Specifications and Test Methods for Biopharmaceuticals (Biotechnology-derived Products / Biological Origin Products)." Please refer to the basic information for the analysis items. 【Features】 ■ Comprehensive support for the characterization analysis of biopharmaceuticals ■ Consistent contract services from test method development to quality testing for biopharmaceuticals ■ Possession of analytical instruments managed in compliance with GMP regulations For more detailed information, please see the "Related Links." If you have any questions or inquiries, please feel free to contact us through the "Contact Us" section on this page or through the "Contact Form" on our official website.

• Other analysis and evaluation services

Our company can conduct a total range of services from validation of mycoplasma detection tests (nucleic acid amplification test: NAT) to actual measurements and technology transfer using analysis equipment managed in compliance with GMP regulations. 【Features】 ■ Over 20 years of experience in mycoplasma detection tests as part of the Eurofins BPT (BioPharma Product Testing) network ■ After technology transfer, tests can be conducted using a method with control DNA, allowing for low-risk and low-cost testing ■ Requests for feasibility studies only are also possible ■ Possession of analysis equipment managed in compliance with GMP regulations The Eurofins BPT network has been focusing on mycoplasma detection tests for many years, including culture methods, and has strengths in regulatory approvals and accumulated know-how overseas. We will utilize this know-how to structure mycoplasma detection tests and propose optimal test designs. For more detailed information, please refer to the "Related Links."

• Other Testing Contract

Our company can conduct E&L testing using analysis equipment managed in compliance with GMP regulations. E&L testing is already essential for applications in the United States and Europe. Recently, it has begun to attract attention domestically due to the rapid growth of the non-oral pharmaceutical market. 【Features】 ■ Over 15 years of experience in E&L testing as part of the Eurofins BPT (BioPharma Product Testing) network ■ Possession of a unique spectral database (LC/MS) capable of identifying over 1,900 compounds ■ Ownership of analysis equipment managed in compliance with GMP regulations ■ Conducting tests domestically with communication available in Japanese Our company transfers over 15 years of experience and extensive know-how from overseas labs to provide suitable guideline selection that meets the needs of various customers in Japan, planning evaluation and management methods according to risk, setting testing methods, and designing long-term leachables testing. Additionally, we offer consultations on stability testing, which has over 20 years of experience, as part of our projects, providing a total solution for approval applications. For more detailed information, please refer to the "Related Links."

• Other Testing Contract