The life-saving anticoagulant heparin belongs to a category of drugs referred to as “biologics.” Heparin is one of the world’s most commonly sold biologics and is included in the World Health Organization’s “Essential Drugs List.” Biologics are important drugs that are made in cells or extracted from living organisms and used to treat serious chronic illnesses, including cancer, autoimmune disorders, hepatitis and diabetes. Stringent quality control of these drugs during the production process is critical. However, determining their quality is more complex than with traditional small molecule pharmaceuticals. A biologic often contains a mixture of related molecules and composition can vary between the different batches produced. Product quality assessment therefore requires highly informative analytical approaches to validate that a product meets the required specifications.
Seminar Overview
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.
Presenter Biographical
Dr. Marco Guerrini
Vice Director G. Ronzoni Institute for Chemical and Biochemical Research Milan Italy. His main field of expertise is the structural activity correlation of carbohydrates using NMR spectroscopy. He contributed to the development of advanced analytical approaches for the characterization of glycosaminoglycans, particularly heparin and low molecular weight heparin.
Dr. Kimberly L. Colson
Business Development Manager Bruker BioSpin Billerica Massachusetts United States
Kim Colson began her scientific career in chemistry with a BA degree from Mount Holyoke College. She then received her PhD in Organic Chemistry from The Penn State University while studying structure elucidation of natural products and molecular dynamics using NMR spectroscopy. With a postdoctoral appointment at Yale University in the Pharmacology department Kim began applying NMR to pharmaceutical applications. She then joined the pharmaceutical industry as a NMR spectroscopist at Bristol Myers Squibb and Burroughs Wellcome where she studied complex natural products, proteins and mechanism of action of natural products. To further expand her knowledge she spent a short time as NMR Facility Director at North Carolina State University and then joined Bruker BioSpin where she has been for the past 20 years. Her roles at Bruker have included NMR applications, business development, and product management. She is product manager for AssureNMR, a NMR software tool for automated quality control analysis. Her focus areas currently include quality control, natural products, metabolomics and biologics.
Dr. Francesca Benevelli
Applications Scientist Bruker Italia S.r.l.
Francesca Benevelli graduated in chemistry in 1994 at the University of Pavia with a thesis on the characterization of secondary metabolites of botanical species. After graduation, she took a position as NMR manager at the University of Pavia. In 1998 she started a PhD in physical chemistry at the University of Cambridge working in the field of solid state NMR under the supervision of Professor Klinowski. She then started a postdoc at the Freie Univesity in Berlin in the group of Professor Limbach. In 2002 she was hired in Bruker Italy as NMR application scientist, supporting experienced customers as well as new-comers to NMR in improving their experience with NMR spectroscopy in different areas.
What to expect
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, 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.
When
November 28th, 2017
Key topics
Using heparin as an example, implementation of the 2D HSQC NMR approach will be described, with a focus on the key parameters and evaluation of sources of variability inherent to the technique. Attention to factors influencing limit of detection, linearity, accuracy and precision are necessary in the development of a robust method for a given material. Another important topic will be how the method can be automated to take advantage of NMR’s inherent reproducibility, reduce operator-to-operator variations and prepare for method validation of this quality control approach. The idea is to develop a method that can not only be used in specialized NMR labs designed to work with this type of drug, but also in the routine control of heparin production and batch release by different pharmaceutical companies. The method was automated using tools in Assure NMR software for qualitative assessment of porcine verses bovine heparin and quantitative analysis of heparins and impurities. The instrument operational performance was also automated to assist with GxP compliance.
Who should attend
The webinar will be of interest to the following individuals:
- Quality managers, scientists and technicians who are responsible for the quality control of pharmaceuticals and/or biologics
- Users of qNMR
- Students considering careers in analytical chemistry and quality assurance