In recent years, the demand for mass spectrometry (MS)-based approaches for structural characterization in quality control of oligonucleotide-based pharmaceuticals has increased increased significantly. Sense strand RNAs with +30 nucleotide building blocks and labile modifications such as N-acetylgalactosamine residues represent thereby a special challenge.
Direct, robust and easy-to-use techniques to fully characterize the nucleotide sequence of highly modified single-stranded RNAs by top down tandem MS. It include a case study for an N-acetylgalactosamine modified RNA sense strand. The approach can be applied on single strand level, as well as on siRNA duplex level in a single electrospray ionization MS (ESI-MS) experiment. Based on this technique, we also developed an efficient and highly sophisticated LC-M/ MS workflow for the characterization of product-related impurities in oligonucleotides. This procedure allows us to reliably predict the modification sites in oligonucleotide impurities to support process development with important structural information.
Presented by Giovanni Calderisi
Watch the full video here, find it at the "CMC development" live area of Bachem360: hub.bachem.com...
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About Bachem:
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides.
The company, which has over 50 years of experience and expertise, provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services.
Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.
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28 авг 2024