Phase appropriate route scouting, salt screening & solid form selection, crystallisation, preliminary safety assessment and first scale-up to few kilo quantities.
At the discovery or med-chem phase it is imperative to make the desired molecule by whichever route it can be made. The aim is to get to the final product and test it for its suitability. Once the leads are identified and decided, it is best to get us involved.
At this juncture the demand for the drug substance increases and must be produced in hundreds of gram quantities to support preclinical tox studies. Based on our extensive experience, we will be able to guide on what is scalable and what can be challenging. We will guide you with creative and innovative route scouting, with priority on delivery of the compound. The aim will be to identify the most promising, scalable route, which can be further perfected in development stages. For drug substances this will also include guidance on screening and selecting the suitable solid form.
At this juncture it will also be ideal to identify the size of end market, what could be the potential demand of the compound, whether there is an intention to invest in an in-house facility for scale-up i.e., technology development or will it be outsourced for scale-up and manufacture. This clarification will help define the development phase and as well as the research and innovation phase.