Robust monosaccharide and sialic acid assays for biologic drugs
Monosaccharide and sialic acid analysis is applicable to all stages of biopharmaceutical development and manufacturing processes including cell line and clone selection, upstream and downstream process development and manufacturing in-process control, batch consistency and release. Sialic acid and monosaccharide analysis is required by ICH Q6B guidelines for biopharmaceutical characterization.
Thermo Fisher Scientific has proven, sensitive workflows based on high performance anion exchange chromatography with pulsed amperometric detection (HPAE-PAD). Our workflow delivers trace performance for monosaccharides and sialic acids without cumbersome and time consuming labeling protocols.
Ion chromatography analysis of monosaccharides and sialic acids workflow
Monosaccharide and sialic acid analysis system
Get best-in-class resolution, sensitivity, and throughput for even the most complex trace level glycan analyses. The versatile Dionex ICS-6000 Hybrid HPIC System is a complete solution for the biopharma carbohydrate applications (monosaccharides, disaccharides, sialic acids, N- and O-linked oligosaccharide analysis, and more). You'll save time and improve reproducibility with precise, automatic eluent generation and sample preparation. Choose from a wide variety of chemistries, detectors, and automation options to fit your needs.
Characterization and monitoring of the glycan profile of therapeutic proteins is critical for drug efficacy and safety. Ion chromatography (IC) is a workhorse technique for this application used by SGS in West Chester PA.
Biotherapeutic proteins, which include antibodies, are becoming the fastest growing category of drugs due to their efficacy for patient health. The complex nature of these large molecules brings major new challenges to the pharmaceutical scientist. Read about the series of four simple workflow solutions we've developed, based on leading technology platforms.