GlycanAssure-200x200

Integrated solutions for N-glycan analysis

Glycosylation analysis is one of the key critical quality attributes of monoclonal antibody– based biotherapeutics. Glycosylation changes can impact a biological drug’s safety, efficacy, clearance, and immunogenicity, making it necessary to accurately detect changes. 

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The Applied Biosystems GlycanAssure HyPerformance APTS System is a rapid N-linked glycan release, labeling, and clean up system that provides flexibility in sample preparation and in glycan analysis while ensuring accurate and consistent data through complete deglycosylation and preservation of sialic acid. The workflow can function in both a manual and hands-free automated fashion and offers outstanding N-glycan yield and reproducibility that can be analyzed via high-throughput capillary electrophoresis (CE) and/or liquid chromatography (LC) platforms.

The Applied Biosystems GlycanAssure HyPerformance APTS System workflow: manual vs. automated

Applied Biosystems GlycanAssure HyPerformance APTS Kits

GlycanAssure HyPerformance APTS workflow offers a seamless glycan sample preparation solution for high throughput clone selection to low throughput characterization/lot release – making it the one solution you need for all your glycan profiling needs. Sample preparation with the GlycanAssure HyPerformance APTS kit is a short and streamlined 3-step workflow with less than 1.5 hours total sample preparation time.

GlycanAssure AutoXpress APTS Workflow using the AutoMate Express

COL13138-7218-AB-Automate-sm-Clip-Logo

The GlycanAssure AutoXpress APTS kit combines the GlycanAssure HyPerformance APTS reagents with the Applied Biosystems AutoMate Express instrument to provides a nearly hands-free workflow solution.

  • A fully automated platform for the 3 steps of the N-glycan sample preparation
  • GlycanAssure HyPerformance reagents supplied in prefilled cartridges
  • Sample preparation time of 1.75 hours for 13 samples
  • Hands-on time of 5 minutes

A fully automated workflow with analysis on CE or LC.

GlycanAssure AutoXpress APTS Workflow using the AutoMate Express

Simplifying sample preparation without compromise

GlycanAssure HyPerformance APTS System offers a simple solution to today’s glycan sample prep workflow challenges by reducing the hands-on time. The workflow utilizes a novel rapid reagent for complete deglycosylation and magnetic bead–based sample preparation and fluorescent dye labeling that preserves sialic acid. Labeled glycans are suitable for analysis via liquid chromatography on the Vanquish Horizon UHPLC or via high-throughput capillary electrophoresis on the Applied Biosystems 3500XL protein quality analyzer. Both the automated and manual workflows provide an end-to-end single sample prep solution that can be used from high throughput clone selection applications to low throughput drug product QC release applications. 

3-Step-Sample-Workflow

Figure 1. GlycanAssure HyPerformance workflow simplifies glycan sample preparation into three steps.
Hands-on-method2

Manual Workflow

  • Streamlined 3-step workflow
  • Complete deglycosylation in 10 min using a novel denaturant
  • High recovery and reproducible results using a magnetic bead-based workflow
  • Total sample preparation time of <1.5 hrs
  • 96-well sample preparation capability

Superior data quality through complete deglycosylation with preservation of sialic acid

An efficient method of glycan release is necessary for accurate analysis. The GlycanAssure HyPerformance APTS kit utilizes a novel rapid reagent providing complete deglycosylation in 10 minutes, equally as effective as time consuming overnight methods.  This enables you to capture all of the glycans that matter.

Many glycan sample preparation and labeling methods cause desialylation. The proprietary chemistry in the GlycanAssure HyPerformance APTS kit helps ensures the preservation of sialic acid.

Glycoprofiling you can depend on

Samples from both manual and automated workflow can be analyzed by high throughput 3500 multi- capillary CE or Vanquish UHPLC, providing flexible options for glycan analysis. The optimized workflow of the GlycanAssure HyPerformance APTS kit yields highly repeatable and robust results, regardless of the analysis method. High-quality data is provided in analysis via LC or high-throughput CE, with comparable results from different sample types.

Comparison of CE and LC results for RNaseB

Highly comparable %RA of N-glycan analysis of a protein therapeutic on CE and LC


High throughput Data Analysis

The flexibility of the GlycanAssure Glycan Analysis system allows for parallel analysis of up to 24 samples on the 3500xL Genetic Analyzer for Protein Quality Analysis for high-throughput and high-resolution glycan analysis. Only 1 -2 ul of sample is required while providing great reproducibility with high separation efficiency.  Six independent sample preparations followed by analysis on the 3500xL CE instrument yielded a CV of less than 10% for all identified peaks demonstrating the high reducibility of the GlycanAssure assay.

Applied Biosystem 3500xL Genetic Analyzer for Protein Quality Analysis
The Applied Biosytems 3500xl Genetic Analyzer for Protein Quality Analysis
CE-High-Reproducibility_17-Peaks
Figure X. Overlay of 6 independent sample preparations followed by CE. The flexibility of the GlycanAssure Glycan Analysis system allows for parallel analysis of up to 24 samples on the 3500xL Genetic Analyzer for Protein Quality Analysis for high-throughput and high-resolution glycan analysis. Only 1 -2 ul of sample is required while providing great reproducibility with high separation efficiency. Six independent sample preparations followed by analysis on the 3500xL CE instrument yielded a CV of less than 10% for all identified peaks demonstrating the high reducibility of the GlycanAssure assay.
Peak # Glycan Average % Area CV%
1 A2 0.33% 9.23
2 A2F 2.2% 10.12
3 A2FB 1.97% 8.4
4 G1FS1 3.56% 3.9
5 Unknown 0.31% 5.32
6 A1 0.52% 3.22
7 A1F 12.61% 4.35
8 A1FB 1.92% 4.87
9 G0F 23.61% 4.01
10 G1FS1 0.77% 5.13
11 G0FB 4.36% 4.17
12 G1F 19.49% 3.46
13 G1F' 9.82% 3.38
14 G1FB 4.15% 1.98
15 Unknown 0.48% 5.1
16 G2F 12.84% 2.5
17 G2FB 1.07% 5.02

Table Y. Average %RA and CV of major glycan peaks from 6 independent sample preparations followed by CE.

The ability to analyze samples in parallel avoids the need for shortened run times to achieve high throughput. The 3500 Series systems for protein quality analysis come with integrated assay-specific GlycanAssure data acquisition and data analysis software for optimum performance and user experience.


Superior UHPLC characterization

Thermo Scientific Vanquish Flex UHPLC

The Thermo Scientific Vanquish Flex UHPLC with fluorescence detection delivers confident GlycanAssure HyPerformance - labelled glycan separations. With a fully biocompatible flow path, proven compliance, and tool-free Thermo Scientific Viper fittings, you can expect to achieve excellent labelled glycan UHPLC performance in retention time stability, sensitivity, and separation efficiency.

Thermo Scientific Chromeleon Chromatography Data System (CDS) Software
Triplicate analysis of NIST mAb standard on LC. 37 peaks with >0.03% relative area were found. Peaks >0.5% show RSD of <5%; Peaks <0.5% show RSD of <10%

The Thermo Scientific Accucore 150 Amide HILIC columns, based on Core Enhanced Technology, provide fast, high-resolution biomolecule separations - without the elevated backpressures required by sub-2µm particles. Analysis of NIST mAb standard prepared with GlycanAssure HyPerformance and analyzed on Vanquish Flex UHPLC yield 37 peaks with high-resolution and high-reproduciblity.

Streamline your laboratory workflow using Thermo Scientific Chromeleon Chromatography Data System (CDS) software. This software delivers superior instrument control, automation, and data processing for compliant GxP biopharmaceutical manufacturing and QA/QC environments. Run your routine UHPLC-FLD released glycan analyses in an enterprise environment - from method creation to final reporting.

Thermo Scientific Chromeleon Chromatography Data System (CDS) Software
Data acquisition software

GlycanAssure software is easy-to-use data acquisition and analysis software for glycans and includes security, auditing, and E-signature (SAE) features. It breaks new ground in user-friendly navigation with an intuitive dashboard design, highly visible buttons for common operations, easy-to-read graphical displays to monitor the state of consumables, simplified plate setup, and a handy maintenance scheduling calendar functionality.

Glycan Analysis Software

GlycanAssure Data Analysis software allows quick viewing of analyzed and un-analyzed glycan samples and quick comparison of different analytical methods. It includes built-in primary analysis with quality control, so you can make decisions about the quality of data as it is produced without the need to transfer output files to other software.

GlycanAssure Software

GlycanAssure software has a full suite of security, auditing, and E-signature features to help enable 21 CFR part 11 compliance.

The Applied Biosystems GlycanAssure HyPerformance System utilizes magnetic bead–based sample preparation and fluorescent dye labeling that preserves sialic acid with complete deglycosylation. Labeled glycans are suitable for analysis via liquid chromatography on the Vanquish Horizon UHPLC or via high-throughput capillary electrophoresis on the Applied Biosystems 3500XL protein quality analyzer.

The Applied Biosystems GlycanAssure HyPerformance AutoXpress kit combines the magnetic bead-based technology and chemistry with the Automate Express instrumentation to provide an out-of-the-box fully automated sample preparation solution.

The Applied Biosystems GlycanAssure HyPerformance provides flexibility in sample preparation and flexibility in analysis method while ensuring accuare and consistent data through complete deglycosyslaton and preservation of sialic acid.

Data acquisition software

GlycanAssure software is easy-to-use data acquisition and analysis software for glycans and includes security, auditing, and E-signature (SAE) features. It breaks new ground in user-friendly navigation with an intuitive dashboard design, highly visible buttons for common operations, easy-to-read graphical displays to monitor the state of consumables, simplified plate setup, and a handy maintenance scheduling calendar functionality.

Glycan Analysis Software

GlycanAssure Data Analysis software allows quick viewing of analyzed and un-analyzed glycan samples and quick comparison of different analytical methods. It includes built-in primary analysis with quality control, so you can make decisions about the quality of data as it is produced without the need to transfer output files to other software.

GlycanAssure Software

GlycanAssure software has a full suite of security, auditing, and E-signature features to help enable 21 CFR part 11 compliance.

The Applied Biosystems GlycanAssure HyPerformance System utilizes magnetic bead–based sample preparation and fluorescent dye labeling that preserves sialic acid with complete deglycosylation. Labeled glycans are suitable for analysis via liquid chromatography on the Vanquish Horizon UHPLC or via high-throughput capillary electrophoresis on the Applied Biosystems 3500XL protein quality analyzer.

The Applied Biosystems GlycanAssure HyPerformance AutoXpress kit combines the magnetic bead-based technology and chemistry with the Automate Express instrumentation to provide an out-of-the-box fully automated sample preparation solution.

The Applied Biosystems GlycanAssure HyPerformance provides flexibility in sample preparation and flexibility in analysis method while ensuring accuare and consistent data through complete deglycosyslaton and preservation of sialic acid.


Webinar Spotlight

A Glycan Analysis Method That Reduces Time and Effort

Johnie Young,
R&D Scientist, Molecular Biology,
Thermo Fisher Scientific 

The GlycanAssure™ HyPerformance sample preparation kit utilizes magnetic bead-based technology, providing rapid and complete release of N-glycans with preservation of sialic acid. The resulting samples magnetic bead-based sample preparation that provides improved analysis on either Capillary Electrophoresis (CE) or Liquid Chromatography (LC) analytical platforms. The kit also provides a simple workflow for glycan denaturation and deglycosylation, labeling of released glycans, and cleanup of excess free dye. 

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Discover a Simple, Robust, and Automated 3-step Workflow N-glycan Analysis on UHPLC and Multicapillary CE

Anahita Eckard, Ph.D.
Staff Scientist, Pharma Analytics, BioProduction
Thermo Fisher Scientific

With a growing number of biotherapeutics in development and fast growth in the biosimilar market - rapid, high-throughput, and accurate N-glycan profiling is essential. Thermo Fisher Scientific has developed a rapid N-linked glycan release, labeling, and clean up method that can function in both a manual and hands-free automated fashion, depending on throughput need. The workflow utilizes a novel rapid deglycosylation reagent for complete deglycosylation and magnetic beads for excess dye clean up.

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