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Process Intensification of a Napabucasin Manufacturing Method Utilizing Microflow Chemistry.

Hirotsugu Usutani1, Kenji Yamamoto1, Kazuki Hashimoto1

  • 1Technology Research & Development Division, Process Research & Development Laboratories, Sumitomo Pharma Co., Ltd., Kasugade-naka 3-1-98, Konohana-ku, Osaka 554-0022, Japan.

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Microflow chemistry enables efficient, safe production of napabucasin, a potential cancer therapeutic. This study demonstrates kilogram-scale manufacturing using microflow technology, improving yield and purity over traditional methods.

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Area of Science:

  • Medicinal Chemistry
  • Chemical Engineering
  • Process Chemistry

Background:

  • Conventional batch reactors have limitations in controlling side products, impacting yield and purity due to heat/mass transfer constraints.
  • Napabucasin is a compound with potential applications in treating colorectal and pancreatic cancers.
  • Microflow chemistry offers enhanced control over reaction parameters compared to batch systems.

Purpose of the Study:

  • To develop a safe and effective manufacturing method for napabucasin using microflow chemistry.
  • To demonstrate the feasibility of scaling up napabucasin production to the kilogram scale using microflow technology.
  • To explore process intensification opportunities offered by microflow chemistry for napabucasin synthesis.

Main Methods:

  • Utilized microflow chemistry reactors for precise mixing and temperature control.
  • Developed a manufacturing process for napabucasin leveraging microflow technology.
  • Conducted a proof-of-concept study for kilogram-scale production.

Main Results:

  • Microflow chemistry allowed for improved control over reaction parameters, leading to enhanced yield and purity of napabucasin.
  • Successful scale-up to kilogram quantities was achieved.
  • Demonstrated process intensification potential for napabucasin manufacturing.

Conclusions:

  • Microflow chemistry is a highly efficient technology for the safe and effective production of pharmaceuticals like napabucasin.
  • This study provides a proof-of-concept for large-scale napabucasin manufacturing using microflow techniques.
  • Microflow chemistry offers significant advantages for improving yields and intensifying pharmaceutical manufacturing processes.