How Solid-State Characterization Shapes Drug Development

Mark Benger is Site Director at Cambrex Edinburgh, Scotland. He holds a graduate degree in Chemistry from Napier Polytechnic, is a Fellow of the Royal Society of Chemistry, and brings 35 years of experience in the pharmaceutical industry.

He specializes in analytical chemistry, particularly the development of analytical methodology supporting API and formulation development and quality control activities — work spanning pre-clinical through registration studies across more than 1,000 new chemical entities and marketed products. His expertise covers analytical development, solid-state sciences, and chemistry, manufacturing and controls.

Asked what role solid-state characterization plays in manufacturability and bioavailability, Benger frames it as an insurance policy. The investment is made up front, before scale becomes a constraint, and it pays out later: doing the characterization work early sharply reduces the likelihood of a program failing as it moves from laboratory quantities into kilogram and then multi-tonne production.