After the lead has been identified, it is important to ensure an optimal process is in place. The process should thoroughly support reliable quantities of API in both pre-clinical and Phase 1 work. The reliability and environmental/health safety of a sound process can not only save millions of dollars in the API synthesis (even in early stages of preclinical development) but also ensures process consistency. Subsequent quantities as needed for both pre-clinical and clinical studies will also be consistent.
Having an optimal process is a critical foundation for the success of every development program. It is equally important that each process never infringes on another party’s intellectual property. Partnering with one of the world’s renowned leaders in process research capabilities, DDA will use our knowledge, experience, and expertise to help avoid any possible infringements.