Eurofins Analytical Science Laboratories, Inc.
Originally established as a subsidiary of Fujisawa Pharma in 1996, Eurofins Analytical Science Laboratories, Inc. (Eurofins BioPharma Product Testing Kyoto: Eurofins BPT Kyoto) joined the Eurofins Group via Astellas Pharma in November 2018. Eurofins BPT Kyoto is the Japanese base of the pharmaceutical analytical division (BioPharma Product Testing) in Eurofins and provides solutions for various analytical testing in the drug development process from new drug development to commercial manufacturing.
Eurofins BPT Kyoto has more than 20 years of GMP experience in conducting analytical studies in compliance with global regulations in USA, EU and Japan and supports method development, method validation, release testing and stability studies for both pharmaceuticals and biopharmaceuticals. In particular, we have vast experience with method development for metal identification and microbial testing.
Eurofins BPT Kyoto also provides formulation development support and foreign matter analysis through advanced expert analysis, such as nondestructive and surface analyses. If a raw material or drug substance/product is found to be contaminated with a foreign matter, it is required to identify the contaminant as soon as possible. Eurofins BPT Kyoto can satisfy customers not only by providing prompt results, but also by presuming the source of the contamination based on our previous experiences in dealing with micro-foreign matters.
Reference standards for drug substances, intermediates and related substances are very important in pharmaceutical analyses. Eurofins BPT Kyoto also provides comprehensive services including storage, quality testing and shipment to manufacturing sites or laboratories.
- GMP compliant
- FDA audited
- PMDA audited