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[V5-S3] New Pharmaceutical Technical Innovation - Continuous Manufacturing and its Driving Forces
Session Chair(s)
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.
Speaker(s)
Continuous Spherical Crystallization Used for Integrated Pharmaceutical Manufacturing
Kohei Tahara, PhD
Gifu Pharmaceutical University, Japan
Associate Professor, Laboratory of Pharmaceutical Engineering
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
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