To meet the rapidly growing industry demand for advanced biologics, Eurofins Analytical Science Laboratories in Kyoto, Japan, is expanding its comprehensive analytical testing capabilities. As part of plans to establish three new dedicated laboratory areas, new state of the art instrumentation has already been installed, including additional biosafety cabinets, next generation imaged capillary isoelectric focusing (icIEF) systems (Maurice) for high precision charge variant analysis, and significantly expanded ELISA and cell based assay (CBA) platforms.
Historically, Eurofins Analytical Science Laboratories has been fully equipped to perform all essential quality control and stability testing for both monoclonal antibody (mAb) and antibody drug conjugate (ADC) active pharmaceutical ingredients (APIs) and finished drug products. With these recent facility upgrades, we are substantially increasing operational capacity to support the highly specialised analytical requirements unique to mAbs and ADCs, ensuring robust and reliable testing for these complex modalities.
Beyond protein characterisation capabilities, the facility includes dedicated Biosafety Level 1 (BSL 1) and Biosafety Level 2 (BSL 2) laboratories. Leveraging this specialised infrastructure, we are progressively expanding our analytical portfolio to fully support viral vector product testing. The microbiology department also brings extensive expertise: in addition to bioburden, sterility, and endotoxin testing, we have recently completed multiple contract studies for disinfectant efficacy testing required for sterile manufacturing facilities, ensuring full compliance with PIC/S GMP Annex 1.
With this enhanced infrastructure and deep scientific expertise, Eurofins Analytical Science Laboratories is committed to supporting pharmaceutical companies operating in Japan by delivering highly reliable testing for both developmental and commercial biologics.
The team also has extensive experience performing the required quality control testing for antibody products imported into Japan. By providing comprehensive in country testing solutions, we help overseas biopharmaceutical companies navigate Japan’s regulatory landscape smoothly and efficiently, enabling successful market entry for their innovative products. For more information, visit: Eurofins Analytical Science Laboratories, Inc. - Eurofins Scientific.