Process Development 101: How Not to Burn Down Your Factory
Or... how to manufacture your API in the right quantity, at the right cost, and in the right time frame
Jonathan Moseley | | Longer Read
Scaling-up chemical processes for the manufacture of small molecule pharmaceuticals is not simply about using a bigger reaction flask. Processes that can easily be accomplished at small scale in the laboratory are often not possible at large scale in factories without significant modification. And that’s why process development is key. Process development serves two key functions. Firstly, to manufacture increasing quantities of the API – perhaps scaling from grams to tons over time – to support ongoing clinical testing of the experimental drug, and to support other development activities, such as formulation. Secondly, process development helps to improve the “recipe” to achieve these increasing scales of manufacture in a timely, safe and economic manner – all without polluting the environment, injuring anyone, or burning the factory down! Process development must consider chemical and physical safety; commercial concerns, such as time, cost, and availability of starting materials; chemical, analytical and engineering aspects; and legal and regulatory requirements.
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