Eurofins Analytical Science Laboratories, Inc.
93, Chudoji Awatacho
Shimogyo-ku, Kyoto
600-8815
Japan
Phone: .
easl.cserv@bpjp.eurofinsasia.com
www.eurofins.co.jp/eurofins-biopharma-product-testing-kyoto
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Originally established as a subsidiary of Fujisawa Pharma in 1996, Eurofins Analytical Science Laboratories (Eurofins BPT Kyoto) joined the Eurofins network via Astellas Pharma in November 2018. Eurofins BPT Kyoto is the Japanese base of the pharmaceutical analytical division (BioPharma Product Testing) and provides solutions for various analytical testing in drug development stages from new drug development through commercial manufacturing.
Eurofins BPT Kyoto has over 20 years of GMP experience in performing analytical studies in compliance with global regulations in the US, Europe and Japan and offers method development, method validation, release testing and stability testing services for pharmaceuticals and biopharmaceuticals. In particular, we have solid experiences in method development for metal identification, microbiological testing, and Extractables & Leachables (E&L) testing.
Eurofins BPT Kyoto also offers formulation development support and foreign matter analysis.
We offer analytical services using CT X-ray, FT-IR microscope, Laser Raman microscope, TOF-SIMS, and XPS etc. We can also perform sampling of small foreign matter in liquid. We have an express service to report within 24 hours.
Reference standards for drug substances, intermediates and related substances are very important in analysis for pharmaceuticals. Eurofins BPT Kyoto comprehensively supports quality control, storage management, and shipment of reference standards.
Accreditations/Certifications/Registrations:
・GMP compliant
・FDA audited
・PMDA audited