From mg to kg: first steps towards a scalable process for drug substances

A drug substance project’s movement from pre-clinical to clinical and then into commercial scale manufacture often presents challenges which can lead to failure. As such, it is important to carefully manage the development process and define necessary processes in order to prevent poor communication or assumptions impacting the success of a project.  

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Anders Högdin, senior sales director, at Recipharm discusses the key differences between medicinal and process chemistry and outlines the steps required to progress a project from medicinal chemistry into a development chemistry environment. He also sheds light on scale-up challenges when moving from clinical to commercial scale drug substance production.

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