Compliant with guidelines from various countries such as JP, EP, and USP, capable of total implementation from validation to actual measurement and technology transfer.
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."
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We are a contract analysis laboratory (Kyoto) that complies with pharmaceutical GMP standards, part of the Eurofins Group, which operates a global contract analysis business. We efficiently and swiftly respond to various testing needs from the early stages of product development to commercialization, while adhering to various regulations. Please feel free to contact us if you have any requests.