Eurofins BPT Kyoto offers foreign matter analysis services for CGT products

Fumihiro Tanaka, Senior Director, Eurofins Analytical Science Laboratories, Inc., FumihiroTanaka@eurofins.com

Like many consumers, Japanese society is typically very concerned by the contamination of products with foreign matters. For example, if a consumer found a foreign matter in their food, it would not be uncommon for this to immediately be taken up by the media and have a major impact on the manufacturer of the food. When it comes to pharmaceuticals, the impact can be even more severe, with some companies suspending the manufacturing of pharmaceuticals until the source of contamination has been formally identified, once a foreign matter has been found. It is therefore not only accuracy that is critical for foreign matter analysis, but also speed. Eurofins Analytical Science Laboratories, Inc. (E-ASL) has more than two decades of testing experience and has continually met the needs of clients by utilising a variety of analytical techniques customised for the type, size, and condition of foreign matters.

Recently, with a shift of modalities, pharmaceuticals such as cell and gene therapy (CGT) products, which require biosafety control, have also appeared, and in turn, the necessity of foreign matter analysis for CGT products has also increased. To respond to several requirements brought about by this shift, E-ASL launched a new service in 2021 and set new rules for the handling of samples up to BSL1 in a new 300m² laboratory. Since then, E-ASL has consistently received more than 25 requests each month. Due to the special techniques required for sampling foreign matters, E-ASL offers these services limited to BSL-1 at this time, but preparations to expand to BSL-2 by devising the necessary techniques is in progress.

BPT Kyoto was a company within the Astellas Pharma group before joining the Eurofins Group in 2018. Many of its analysts have expertise in the manufacturing processes of pharmaceuticals. This experience makes it possible to not only provide reliable results but also to infer the cause. By providing foreign matter analysis services for CGT products over time, it will be possible to continue building trusting relationships with clients.

For more information, visit: www.eurofins.co.jp/eurofins-biopharma-product-testing-kyoto/