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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V5-S3] New Pharmaceutical Technical Innovation - Continuous Manufacturing and its Driving Forces

Session Chair(s)

Hirofumi  Takeuchi, PhD

Hirofumi Takeuchi, PhD

Professor, Laboratory of Pharmaceutical Engineering

Gifu Pharmaceutical University, Japan

“Continuous Manufacturing” is a quite new innovative technology in the pharmaceutical industry, which will achieve the big cost reduction in manufacturing of the pharmaceutical drugs, while the continuous manufacturing is a major process in other industries, e.g., petroleum or food products. The continuous manufacturing is a process that the material(s) and product are continuously charged and discharged from the system, respectively, throughout the duration of the process in the drug manufacturing. In this session, the key experts from the regulator, industry and academia will discuss the regulatory and quality considerations for the continuous manufacturing and its driving forces.


Kohei  Tahara, PhD

Continuous Spherical Crystallization Used for Integrated Pharmaceutical Manufacturing

Kohei Tahara, PhD

Gifu Pharmaceutical University, Japan

Associate Professor, Laboratory of Pharmaceutical Engineering

Ryutaro  Shimono

Janssen's Experience to Introduce Innovative Continuous Manufacturing (CM)

Ryutaro Shimono

Janssen Pharmaceutical K.K., Japan

CMC Sciences Department, Regulatory Affairs Division, R&D Division

Issei  Takayama, DrSc

Current Regulatory Considerations and Challenges for Continuous Manufacturing of Pharmaceuticals

Issei Takayama, DrSc

Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Japan

Reviewer, Office of New Drug IV