Well-proven for the qNMR and quality control of small molecule APIs and raw materials, AssureNMR can now efficiently and accurately evaluate complex mixtures such as biologics, biofluids, and cell culture media. The Higher Order Structure (HOS) of Biologics are evaluated using a rapid similarity test, PROFILE1, or in more detail using HSQC analysis. Targeted fingerprinting enables identification and quantification of key metabolites of cell culture media to indicate when material is out of specification required for optimal production. I identification of components is enhanced by access to large, public databases. CRAFT aids in quantification by evaluating time domain data gaining freedom from traditional errors in processing.
Marco Guerrini from Ronzoni Institute, an expert in the analysis of the biologic heparin, said: “AssureNMR increases the analysis speed and is customizable. It allows the skilled NMR user to automate their workflow and make their sophisticated method of NMR acquisition and analysis accessible to any NMR lab, even one without an expert in the field of glycosaminoglycans.”
Anthony Ribeiro, Ph.D., of Duke University Medical Center said: “These features represent major enhancements to the AssureNMR software package for the detailed analysis of biofluid systems.”
1 L. Poppe et al., Anal. Chem. 2013, 85, 9623−9629; L. Poppe st al., Anal.Chem. 2015, 87, 5539-5524.