Mass Spectrometry From Discovery To Launch

By Carsten Kroeger and Stefan Lehnert

Mass spectrometry (MS) has transformed from a specialized research technique into a cornerstone analytical method used throughout the entire drug development lifecycle. Originally limited by high cost, complexity, and long measurement times, MS now offers rapid, precise identification and characterization of molecules in complex mixtures. Its ability to separate ionized compounds by mass‑to‑charge ratio produces highly specific molecular fingerprints that enable accurate detection of structural variants, impurities, and critical quality attributes. These capabilities make MS indispensable not only in early discovery but also in regulated environments such as GMP manufacturing and product‑release testing.

Dramatic advances in instrumentation and computing have reduced experimental timelines from weeks to under an hour. Modern MS systems are smaller, more sensitive, and able to resolve subtle molecular differences that were previously undetectable. Improvements in data processing now allow gigabytes of spectral information to be analyzed in real time, eliminating the need for extensive chromatographic separation in many cases.

As a result, MS supports key workflows across discovery, development, commercialization, and long‑term life cycle management, including characterization of biologics, monitoring of quality trends, and ensuring the accuracy and consistency of drug products over time.