Product quality control of complex drugs like heparin requires highly informative analytical approaches to validate that a product meets the required specifications. In the upcoming webinar, Bruker Biospin discusses 2D NMR techniques and their automation for an enhanced analysis of product quality and variablity between batches of complex drugs like heparin.
This webinar will introduce a technique called 2D heteronuclear single quantum coherence (HSQC) NMR spectroscopy for assessing the quality control of heparin. Currently, this is achieved using 1D NMR spectroscopy, following the indication of international pharmacopoeia. However, although 1D spectra can help to confirm the chemical structures of heparin products, it cannot readily identify variability in its composition between batches, which can occur due to differences in the purification methods used and the extraction source selected. The 2D HSQC NMR spectroscopy method, on the other hand, can be used to detect this variability. Once established, the method was automated to take advantage of NMR’s inherent reproducibility and reduce operator to operator variations and prepare for method validation of this quality control approach.
The beginning of the webinar will see Bruker BioSpin’s Business Development Manager, Kimberly Colson, give a general overview of the importance of biologics in the world of pharmaceutics. Chemical and biochemical research expert, Dr. Marco Guerrini, from the Ronzoni Institute, will then describe the 2D HSQC NMR method, which provides detailed information on batch-to-batch compositional differences for the qualitative and quantitative assessment of heparins and impurities. Also from Bruker BioSpin, Applications Scientist, Francesca Benevelli, will show a short movie demonstrating how the complete workflow is performed, starting with the sample, through to the final report, as well as how the process can be automated
The webinar will run on November 28th, 2017 at the following times: