Developing a small molecule active pharmaceutical ingredient (API) is often a risky process. Reaching the goal, be it first in human studies or commercial manufacture, requires data and material without incurring unnecessary delays or impact on costs. Therefore, it’s important to start thinking about process steps and scalability early.

Selection of the appropriate techniques and assays, and their application in well-managed analytical programs, can simplify the process of deformulation and ensure a speedy route to market.