Innovating with Process Development: Why 'how it's made' matters

Process development is important to integrate into an early innovation. In order for a therapeutic to be a successful business, be scalable, distributable, marketable and to ensure an exceptionally high-quality product is being tested from the beginning to ensure robust lot-to-lot consistency.

Meaningful synthesis routes designed for downstream scalability and replicatability matter for patents but also for product quality. In order to minimize unnecessary data acquisition, re-validations and repeated workflows downstream, it is best to start early molecule assessment with the end-product in mind at the beginning.

A scalable synthesis process that yields a target molecule for early-molecule-assessment (EMA) is exceptionally helpful in streamlining work, because the synthesis of the first product tested is also the same synthesis of the final scalable product tested.

Conversely, a small-scale process that has a low yield percentage and does not reflect a process with the potential to scale-up the manufacturing is not streamlining the workflow for a new therapeutic entering the clinic.

The way something is made is just as important as what is made. That is because the impurity proflie for a small batch will have a unique impurity profile, and if the scale-up requires a different route then it will generate a new unique set of impurities and a new impurity profile. This means the scale-up batch will need to undergo the same analytical testing and validations (in vitro and in vivo testing) that a small-scale batch would have already underwent, because the two methods may have created vastly different impurity profiles and need to be compared for these potential risks.

If a synthesis process has the potential to scale-up from the very beginning and have the scalable processes produce product that can be tested in early-molecule assessment, then the long term vision is built-in from the very beginning.