A mixture of oligomannose glycan standards, with over 90% purity as assessed by HPLC. The high mannose glycans included in the mixture is M5, M6, M7, M8 and M9.

Our new High Mannose Glycan Standard Library is a test standard used both in FDA- and EMEA-approved assays worldwide and also with N-glycan analysis of biological samples for precision medicine.

Specifically, this library can be used as a reference standard for high mannose glycans typically monitored in the manufacturing of biotherapeutics. It can also be implemented as a process control to assess the performance of a glycan labelling protocol and/or a system suitability standard for the analytical platform.

The use of standards is part of the guidelines listed in the ICH Topic Q6B Specifications: Test Procedures and Acceptance Criteria for biotechnological/Biological Products. They are beneficial for biotherapeutics development, testing of biosimilars and supporting regulatory submissions.

Biopharmaceutical applications: - Quality control half-life monitoring of biotherapeutics (e.g. Monoclonal Antibodies). - Identifying truncated glycosylation that indicates manufacturing issues affecting cell culture health.

This library combines six oligomannose N-glycan oligosaccharides extracted from porcine thyroglobulin and qualified by MS, HPLC and NMR analysis to meet the high purity and quality standards required by advanced analytical techniques. 

• MAN-9 – oligomannose N-glycan with 9 mannose residues

• MAN-8 – oligomannose N-glycan with 8 mannose residues

• MAN-7 – oligomannose N-glycan with 7 mannose residues

• MAN-6 – oligomannose N-glycan with 6 mannose residues

• MAN-5 – oligomannose N-glycan with 5 mannose residues

Table 1. Glycan names and structures of each peak from the chromatogram. 

Our standards are supported by complete documentation. The certificate of analysis contains the results from the testing used to characterize the material across a complete range of quality characteristics. These standards are well-characterised with documented purity. Each vial contains approximately 10µg of oligomannose N-glycans.

Figure 1. Chromatogram of Procainamide-labelled Oligomannose N-Glycans . Table 1 shows peak assignments.