Contributing to human resource development on biologics in Asia-Pacific
I am Uchida, a professor at Kobe University. As the head of this Center of Excellence (CoE) for biotherapeutic products, I am delighted that we are able to offer you a Biologics Workshop that will be conducted every year.
Kobe University happens to be the second CoE-certified organization in Japan from 2020, and has the honor of being the first academic institution to obtain certification in Japan. Our facility is located in Port Island, Kobe City, Hyogo Prefecture, which is one of the largest biomedical technology clusters in Japan.
This CoE specializes in process development and GMP management of biotherapeutic products. The production process and GMP management are complementary to each other. Understanding the contents of both fields is the key to developing biologics and producing them safely under GMP control.
In order to learn these efficiently, we are preparing training on cell culture, purification processes, related analytical methods, and mock inspection programs for GMP facilities and will provide them to inspectors and government officials from countries participating in Asia-Pacific Economic Cooperation (APEC).
We are working in association with the Biologics Center for Research and Training (BCRET) and the Manufacturing Technology Association of Biologics (MAB) union in the same area. BCRET will be in charge of the training on cell culture, purification processes, and related analytical methods, and MAB will provide a simulated GMP facility for mock inspections. Pharmaceuticals and Medical Device Agency (PMDA) instructors also participate to improve the quality of training.
Since it has been difficult to meet in person for the past two years due to the COVID-19 pandemic, we have replaced hands-on training with video learning and web training. However, if we are able to travel safely from all over the world, we will join you in Kobe. We hope to meet face to face.
Kazuhisa Uchida
Professor
Graduate School of Science, Technology and Innovation
Section Director of Biologics Division
Engineering Biology Research Center
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