Drug development is the process of bringing a new pharmaceutical drug to production once a new molecular entity (NME) has emerged from the drug discovery process. Such a new NME has promising activity against a particular target.
In pre-clinical development, safety, toxicity, pharmacokinetics, and metabolism of this NME has to be characterized, together with a recommendation for dosage and schedule, prior to any human clinical trials. Additionally, physicochemical properties of the NME must be determined. Important parameters are the chemical makeup, molecular and crystal structure as well as related important properties such as stability and bioavailability. Impurity profiling and understanding of the polymorphic landscape are critical for proceeding towards clinical trials. Further development processes include scale-up and suitability for packaging while thoroughly analyzing and monitoring any effects these processes may have on the NME; for example, changes in the impurity profile, (dis)appearing polymorphs and much more. Once a drug candidate emerges with acceptable efficacy and safety profile, clinical testing can start, paralleled by continuous property characterization.
Bruker offers a wide range of techniques, methods, and applications for NME characterization supporting the most important drug development processes: Full molecular and crystal structure characterization and thus structure-related properties, impurity profiling, potency quantification, and much more. Bruker's unique suite of mass spectrometers, NMR systems, FT-IR/FT-NIR, RAMAN as well as XRD and XRF instruments provides valuable solutions to deliver highly complementary data that enhances the overall knowledge of the drug candidate and aids decision-making towards manufacturing and final regulatory approval.