Next&Bio, KIST to co-develop OECD guidelines to validate organoids as alternative for animal test

Next&Bio and Korea Institute of Science and Technology (KIST)’s European Research Institute have signed a joint research agreement to register guidelines for the “OECD adverse outcome pathway (AOP) verification act” to replace animal testing with organoids.

Under the accord, the institute will register the OECD guidelines, share infrastructure for research performance, and connect researchers and research institutes in Europe. Next&Bio, for its part, will develop related technologies to establish guidelines based on mass production and storage technologies of standardized organoids.

Over the past two years, the two sides have collaborated to establish organoid-based animal replacement testing protocols, develop AOP models, and establish guidelines for OECD standard operational procedures and operating procedures (SOP).

Next&Bio and KIST prepared an evaluation protocol for animal replacement testing methods based on liver-lung diseases. They established two AOPs by analyzing toxicity information related to acute respiratory distress with death through ACE2 receptor binding of Covid-19 (SARS-CoV-2) and liver toxicity induced pulmonary fibrosis through ACE2 receptor binding.

"Organoids cultivated in 3D are effective alternatives to animal testing and clinical trials, but this research is still in its infancy, with no current internationally accepted standard,” said Kim Young-jun, head of the Environmental Safety Research Group at KIST European Research Institute.

Kim said the inclusion of the AOP of Animal Alternative Testing Methods in the OECD is a very encouraging achievement, adding that if they succeed in listing these methods in the OECD guidelines, it will be meaningful for Korea's leadership in the organoid industry.

Next&Bio Co-CEO Lee Hyun-sook said, "Organoids can evaluate the efficacy and safety of drugs by simulating patient-derived organizations. We will continue to develop organoid culture technology so the results of this joint study can be successfully reflected in the OECD guidelines.”

Stressing that they have extensive experience in organoid analysis and efficacy and toxicity evaluation of new drug candidates based on differentiated culture and analysis technologies, Co-CEO Lee Young-Wook added that through this research cooperation, he hoped to establish a network with various research institutes in Korea and Europe.