Method Development and Impurity Control in Late-Phase API Manufacturing

Inside the Laboratory is a joint series with LCGC and Spectroscopy, profiling analytical scientists and their research groups at universities all over the world. This series spotlights the current chromatographic and spectroscopic research their groups are conducting, and the importance of their research in analytical chemistry and specific industries. In this “Inside the Laboratory –– Women in Separation Science” special edition PDF, we profile four industry leaders and the impact that their research is having in specific fields such as environmental analysis, forensics, national security, and drug development.

Biozen dSEC-7 accurately resolves AAV serotypes 5, 8 and 9 monomer from aggregates in under 10 minutes with consistent results across different mobile phase conditions.

Photodegradation of plastic products is known to accelerate weathering and the resulting release of chemical additives and particles to the environment, however these processes are complex. Here, eight different plastic consumer products were leached in double-distilled water under exposure to strong ultraviolet (UV) light for ten days, and the chemical composition of the leachates was compared to their respective dark controls. The leachates and plastic particles were investigated with a wide battery of chemical-analytical tools to broadly characterize the underlying processes and possible hazards. These covered (a) metal(loid) analysis, (b) microplastic analysis, (c) analysis of >70 organic target analytes and (d) nontargeted screening of the extracts.

We present a reliable NanoPak-C All Carbon SPE method for extracting and detecting 15 OCPs from small quantities of soil (100 mg) and river water (200 µL) samples.

This application note demonstrates the performance of BioCore SEC columns for determining aggregation and fragmentation associated with antibody-based biotherapeutics.

This application note demonstrates a novel composite technology that enhances reproducibility of solid phase extraction compared to a traditional loose packed format.