From mg to kg: first steps towards a scalable process for drug substances
Taking a drug substance from pre-clinical to clinical and then commercial scale manufacture can be challenging. The development process must be carefully managed and processes clearly defined. There are also key differences between the goals of medicinal and process chemists that should be understood. For example, during medicinal chemistry, the diversity and flexibility of the synthetic route is important, while in process chemistry, a practical, safe and cost-effective process must be found to synthesise the compound on a large scale.
In this webinar, Anders, PhD, Senior Sales Director at Recipharm discusses:
- the common challenges companies encounter during upscaling.
- the key considerations during the medicinal and process chemistry planning phases
- the regulatory requirements
- the steps companies can take to streamline the process