製薬プロセスシステム工学特論

The aim of this advanced lecture is to understand the manufacturing processes of pharmaceuticals. First, an overview is given on the pharmaceutical industry with highlighting the characteristics of the products and processes. Second, major processes are introduced for the manufacturing of small-molecules (i.e., products synthesized by chemical reactions) and biologics (i.e., products synthesized from biological sources). Third, so-called Good Manufacturing Practice (GMP) is introduced as the unique and strict quality standard of pharmaceutical manufacturing. The lecture wraps up with a lecture of the latest topics in the industry. The primary language of the lecture is English.