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Functionalization and Dispersion of Carbon Nanomaterials Using an Environmentally Friendly Ultrasonicated Ozonolysis Process
Published on: May 30, 2017
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Development of a Commercial Process To Prepare AMG 232 Using a Green Ozonolysis-Pinnick Tandem Transformation
Brian M Cochran1, Michael T Corbett1, Tiffany L Correll1
1Pivotal Drug Substance Technologies , Amgen Inc ., One Amgen Center Drive , Thousand Oaks , California 91320 , United States.
The Journal of Organic Chemistry
|December 18, 2018
Summary
A novel manufacturing process for AMG 232 ensures high purity drug substance. Key innovations include unique reagents and a safe ozonolysis method, achieving 99.9% purity and 49.8% yield.
Area of Science:
- Chemical Engineering
- Process Chemistry
- Pharmaceutical Manufacturing
Background:
- Developing efficient and scalable manufacturing processes is crucial for pharmaceutical production.
- Ensuring high purity of the final drug substance is a primary requirement.
Purpose of the Study:
- To develop a robust commercial manufacturing process for AMG 232.
- To achieve high purity and yield of the AMG 232 drug substance.
Main Methods:
- Utilized a novel Vilsmeier reagent (methoxymethylene-N,N-dimethyliminium methyl sulfate) for alcohol activation.
- Employed a stable isopropyl calcium sulfinate for sulfone intermediate preparation.
- Implemented a safe aqueous ozonolysis process in batch or continuous mode.
- Controlled purity via effective salt crystallization for impurity rejection.
Main Results:
- The developed process successfully manufactured AMG 232 drug substance.
- Achieved a high purity of 99.9% (LC area %).
- Obtained an overall yield of 49.8% from the starting material DLAC (1).
Conclusions:
- A robust and scalable manufacturing process for AMG 232 has been established.
- The process incorporates innovative chemical steps ensuring high purity and yield.
- This development facilitates the commercial supply of high-quality AMG 232.
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