Abstract
For over 30years high-performance anion-exchange chromatography with pulsed amperometric detection (HPAEC/PAD) has been an extensively used technique for carbohydrate analysis in the biotechnology industry. This article reviews the basic principles of HPAEC/PAD separation and detection technology and provides an up-to-date description of the chromatography columns, equipment, and accessories used to execute HPAEC/PAD methods. The major applications of HPAEC/PAD in the biotechnology industry and how those applications are used to characterize glycoprotein biopharmaceuticals, including monoclonal antibodies, are reviewed. These applications are monosaccharide and sialic acid analyses for determination of a glycoprotein's carbohydrate composition, and oligosaccharide (glycan) profiling. Coupling the later application to high-resolution accurate mass (HRAM) mass spectrometry is used to deduce a therapeutic glycoprotein's oligosaccharide structures. HPAEC/PAD oligosaccharide profiling is also demonstrated to be part of consistency and comparability analyses during the production of a therapeutic glycoprotein. Other topics reviewed include application of HPAEC/PADs to vaccine development and assay, to assay of aminoglycoside antibiotics, and human milk oligosaccharides. This article also discusses how HPAEC/PAD has been used in United States Pharmacopeia drug product and drug substance monographs, and general chapters.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
More From: Reference Module in Chemistry, Molecular Sciences and Chemical Engineering
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.