“In pharmaceutical development, uncertainty is not an abstract scientific inconvenience. It has a cost, a timeline, a regulatory consequence, and ultimately a patient impact. A promising medicine may have strong biological rationale, compelling early data, and significant commercial potential, yet still face a fundamental question: do we truly understand the product well enough to develop, manufacture, approve, and supply it with confidence?
“Analytical chemistry helps answer that question. It transforms molecular complexity into measurable evidence. It tells development teams what a product is, how pure it is, how stable it remains, what impurities it contains, how it behaves under stress, whether batches are comparable, and whether a manufacturing process is under control. These are not merely technical questions. They influence whether a company advances a program, repeats a study, changes a process, delays a filing, releases a batch, responds to a regulator, or invests in commercial capacity.”
Nithya Karakala, Veranova ARD Scientist, spoke to Pharma Focus Europe about how analytical chemistry reduces uncertainty across pharmaceutical development.
Read Pharma Focus Europe Article
