OSD
When taking products from pre-clinical to clinical and then to commercial scale, chemists encounter several processing and scalability challenges. As such, development of a comprehensive process should be initiated in the very early stages of a project in order to minimise the likelihood of any challenges impacting the overall outcome of a project.
There is no substitution for experience when it comes to taking substances from pre-clinical to clinical and then to commercial scale.
In this article Anders Högdin, phD, senior sales director, at Recipharm discusses the production route of moving a drug substance from mg to kg. He also assesses the scalability and processing challenges experienced during the scale-up process and outlines the key considerations during the medicinal and process chemistry stages.