Standards & Controls

Glycan Standards & Controls

Ludger has a range of system suitability standards, process controls and reference standards for different applications including the analysis of sialic acids, monosaccharides, glycan profiling and characterisation. We provide a variety of unlabelled N-glycans (N), O-glycans (O), oligosaccharides, glycoproteins / glycopeptides and glycan library standards. Furthermore, our catalogue of standards also includes a large range of N- and O- glycan standards fluorescently labelled with 2-aminobenzamide (2-AB), 2-AA (2-aminobenzoic acid), procainamide, 8-aminopyrene-1,3,6-trisulfonic acid (APTS) and permethylated glycan standards. We also provide quantitative glycan and glycopeptide standards under the brand name Ludger BioQuant.

A key component in a well-designed analytical strategy is the inclusion of standards.

Standards: i) help with characterisation, ii) allow quantitation, and iii) provide vital information on the performance of an analytical process.
Example: in a QbD framework, glycan standards that match the GCQAs which have been identified for optimised drug function can be used to ensure that the analytical methods chosen for characterisation provide the necessary data required to monitor the drug realisation process

The data acquired when using standards allow the analyst or reviewer to judge whether a specific stage in the process or the sample itself is in or out of specification.
Glycan standards are used for different applications during glycan analysis and can be broken down into four broad categories: system suitability standards, process standards, reference standards, and quantitative standards.

Workflow:

Ludger Glycan Standards Workflow

The Standards Table below shows which standards can be used for best practice during the analysis of sialic acids, monosaccharides, N-glycans and/or O-glycans.
These fall into the following categories;

  1. System suitability standards enable an analyst to test the holistic functionality of an analytical system (e.g. chromatographic, mass spectroscopic and/or CE) and evaluate whether it is adequate for its intended use.

  2. Process standards or process controls are used to verify that part of or an entire process has worked correctly. There are four main categories for processes standards in glycoanalysis: release, labelling, release followed by labelling and exoglycosidase sequencing

  3. Reference standards allow for characterisation by comparison. This can be accomplished by the direct comparison of the chromatographic or electrophoretic retention time of an unknown to that of a standard whose structure have been fully characterised. Additionally, primary assignment of unknown structures can be accomplished by comparison of their GU (Glucose unit) values (obtained using glucose homopolymer (GHP) standard) with glycans whose GU values are in databases or in the literature.

  4. Quantitative glycan standards are used to determine the absolute amount of an analyte in a sample. They can also be used to quantify the efficiency of a process.




2AB labelled core 1 O- glycan, C1

CAB-C1-01

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Core 1 2-AB labeled glycan Galactose-ß-(1-3)-GalNAc

A1 glycan (A2G2S1, G2S1)

CN-A1-10U

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Monosialyated biantennary N-glycan that contains one terminal sialic acid residue. m/z: 1931.6876

A1 glycan (A2G2S1, G2S1), APTS labelled

CAPTS-A1-01

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APTS labeled monosialo biantennary oligosaccharide

A1F glycan (FA2G2S1, G2FS1), procainamide labelled

CPROC-A1F-01

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Procainamide labeled fucosylated monosialo biantennary oligosaccharide

A2G2S2 quantitative glycopeptide standard

BQ-GPEP-A2G2S2-10U

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The glycopeptide standard is comprised of an A2G2S2 glycan attached to the asparagine amino acid of a peptide with the sequence Lysine-Valine-Alanine-Asparagine-Lysine-Threonine (KVANKT), 10µg.m/z: 2865.1763

Alpha-Gal standard (2-AA labelled)

CAA-ALPHAGAL-01

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The 2-AA Alpha Gal glycan is a linear trisaccharide with sequence linkages Gal-alpha(1-3)-Gal-beta(1-4)-GlcNAc.

Glucose homopolymer ladder (2-AA labelled)

Glucose homopolymer ladder (2-AA labelled)

CAA-GHP-30

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2-aminobenzoic acid labelled glucose homopolymer ladder for use as a calibration standard for HPLC and MS analysis of glycans, 30 runs.

IgG N-glycan library (unlabelled)

IgG N-glycan library (unlabelled)

CLIBN-IGG-01

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IgG N-glycan library, unlabelled, 25 μg

Mannose 8 quantitative standard

BQ-CN-MAN8-10U

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The BioQuant quantitative Man8 glycan is a purified and quantified glycan standard which can be used as an internal standard and positive control for quantitative analysis (e.g. monosaccharide analysis).

N-acetylneuraminic acid qualitative standard

N-acetylneuraminic acid qualitative standard

CM-NEU5,9AC2-01

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5-N-acetyl-9-O-acetyl neuraminic acid standard (Neu5,9Ac2).

Sialic acid reference panel

Sialic acid reference panel

CM-SRP-01

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CM-SRP-01 panel is a standalone product as well as a component in the LudgerTag DMB sialic acid release and labelling kit (LT-KDMB-A1). This kit and the panel can assist you in performing sialic acid analysis which is a regulatory requirement to monitor the level and types of sialic acids during all stages of biopharmaceutical realisation.

Sialidase testing panel (2-AB labelled)

Sialidase testing panel (2-AB labelled)

CAB-STP-NEUAC-01

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The Sialidase Testing Panel contains a mixture of α2-3, α2-6, and α2-8 sialylated oligosaccharides labelled with either 2-AB or procainamide. They were developed as a process control for sialidase digestions. Applied alongside the samples, it demonstratesshows that the enzymes have the expected specificity.

2AB labelled sialylated core 1 O glycan, C1S(3)1

CAB-C1S(3)1-01

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2-AB labelled sialylated core 1 O-glycan, C1S(3)1

A1 glycan (A2G2S1, G2S1)

CN-A1-20U

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Monosialyated biantennary N-glycan that contains one terminal sialic acid residue. m/z: 1931.6876

A1F glycan (FA2G2S1, G2FS1), APTS labelled

CAPTS-A1F-01

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APTS labeled core-fucosylated monosialo biantennary oligosaccharide 20 picomoles

A3 glycan (A3G3S3), procainamide labelled

CPROC-A3-01

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Procainamide labeled triantennary oligosaccharide

Alpha-Gal standard (2-AB labelled)

CAB-ALPHA-GAL-01

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The 2-AB Alpha Gal glycan is a linear trisaccharide: Gal-alpha(1-3)-Gal-beta(1-4)-GlcNAc.

Fetuin glycoprotein standard

Fetuin glycoprotein standard

GCP-FET-05

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The Fetuin Glycoprotein Standard is a highly sialylated glycoprotein standard which can be used as a positive control during glycan release and labelling (particularly for DMB sialic acid analysis). Fetuin exists in a variety of glycoforms containing bi-, tri-, and tetraantennary N-linked oligosaccharides with variable sialylation, as well as O-linked glycans.

Glucose homopolymer ladder (2-AB labelled)

Glucose homopolymer ladder (2-AB labelled)

CAB-GHP-30

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2-aminobenzamide labelled glucose homopolymer ladder for use as a calibration standard for HPLC and MS analysis of glycans, 30 runs.

IgG N-glycan library (2-AB)

IgG N-glycan library (2-AB)

CAB-IGG-01

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IgG N-glycan library, 2AB labelled, 200pmol. (n.b. as this is already labelled it can be run directly on UHPLC) .  A mixture of 2AB labelled fucosylated bi-antennary complex-type N-glycans (oligosaccharides) released from human IgG antibody glycoprotein.

N-acetylneuraminic acid qualitative standard

N-acetylneuraminic acid qualitative standard

CM-NEU-AC-01

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N-acetylneuraminic acid (Neu5Ac or NANA) quantitative standard, 1 nmol

Sialidase testing panel (procainamide labelled)

Sialidase testing panel (procainamide labelled)

CPROC-STP-NEUAC-01

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The Sialidase Testing Panel contains a mixture of α2-3, α2-6, and α2-8 sialylated oligosaccharides labelled with either 2-AB or procainamide. They were developed as a process control for sialidase digestions. Applied alongside the samples, it demonstratesshows that the enzymes have the expected specificity.

2AB labelled sialylated core 1 O glycan, C1S(3)1

CAB-C1S(3)1-02

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2-AB labelled sialylated core 1 O-glycan, C1S(3)1

A1F glycan (FA2G2S1, G2FS1)

CN-A1F-10U

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Biantennary N-glycan that contains terminal sialic acid residues, and fucosylation on the core GlcNAc. m/z: 2077.7455

A2 glycan (A2G2S2, G2S2), APTS labelled

CAPTS-A2-01

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APTS labeled disialylated biantennary oligosaccharide

Chitotriose quantitative standard (2-AB labelled)

BQ-CAB-CHI-01

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The 2AB labelled chitotriose standard is a fluorescently tagged linear tri-N-acetylglucosamine quantitative standard, 100pmol. m/z 748.3

FA2G1 glycan (G1F), procainamide labelled

CPROC-FA2G1-01

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Procainamide labeled fucosylated, asialo, monogalactosylated biantennary oligosaccharide

Fetuin glycoprotein standard

Fetuin glycoprotein standard

GCP-FET-250U

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The Fetuin Glycoprotein Standard was developed for use as a positive control during glycan release and labeling (particularly for DMB sialic acid analysis). Fetuin exists in a variety of glycoforms containing bi-, tri-, and tetraantennary N-linked oligosaccharides with variable sialylation, as well as O-linked glycans.

Glucose homopolymer ladder (procainamide labelled)

Glucose homopolymer ladder (procainamide labelled)

CPROC-GHP-30

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Procainamide labelled glucose homopolymer ladder for use as a calibration standard for HPLC and MS analysis of glycans, 30 runs.

IgG N-glycan library (APTS)

IgG N-glycan library (APTS)

CAPTS-IGG-01

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IgG N-glycan library, APTS labelled, Amount: 10pmol.

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