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Therapeutic Antibody N-Glycan Analysis Service

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Defining the glycan profile of therapeutic antibodies, a vital determinant of their function and stability, poses significant challenges due to the limitations of traditional, cumbersome analytical techniques. Creative Biolabs' Therapeutic Antibody N-Glycan Analysis Service directly addresses this need. Utilizing a state-of-the-art high-resolution mass spectrometry platform, we perform in-depth characterization of glycosylation patterns. This enables precise, semi-quantitative assessment and integrated multi-attribute evaluation, delivering the critical data required to advance your biotherapeutic development, ensure stringent quality oversight, and facilitate robust biosimilarity assessments.

Introduction

Established techniques for N-glycan profiling, such as fluorophore-tagging of enzymatically liberated glycans, often involve protracted procedures and face analytical constraints, including potential structural loss or incomplete resolution. Here, we present a validated subunit-level strategy employing hydrophilic interaction liquid chromatography coupled with high-resolution mass spectrometry. This methodology facilitates the precise, high-fidelity, and semi-quantitative analysis of glycoforms through the characterization of ~25 kDa proteolytic fragments. As an efficient and multi-attribute platform, it serves as a viable successor to conventional workflows, delivering critical data to support both quality assurance and the informed development of antibody therapeutics.

Fig.1 Advanced N-Glycan profiling for mAb development. (OA Literature) Fig.1 Complete N-Glycan characterization for therapeutic antibodies. 1

Therapeutic Antibody N-Glycan Analysis Service at Creative Biolabs

Creative Biolabs' Therapeutic Antibody N-Glycan Analysis Service delivers in-depth, high-fidelity characterization of antibody glycosylation patterns. It quantifies pivotal quality attributes, such as core fucosylation levels, that directly influence therapeutic potency and pharmacokinetic profiles. Our integrated platform generates rapid, accurate insights from microgram quantities, enabling risk mitigation in development and ensuring product consistency from candidate selection through regulatory filings.

Beyond our standardized Therapeutic Antibody N-Glycan Analysis, our Therapeutic Antibody Glycan Characterization platform offers an extended suite of specialized and in-depth services, designed to deliver glycosylation insights that exceed routine analytical scope. We are available to discuss any specific analytical needs or to assist in developing tailored solutions. Please do not hesitate to reach out to our specialists for further consultation.

What We Can Offer

We provide a complete portfolio of N-glycan analysis solutions, covering rapid high-throughput profiling, precise site-specific mapping, and intact protein screening, all reinforced by orthogonal analytical methods to ensure conclusive structural elucidation.

Featured services of therapeutic antibody N-Glycan analysis service at Creative Biolabs. (Creative Biolabs Original)

Our Service Process

Required Starting Materials:

Key Steps:

Workflow of therapeutic antibody N-Glycan analysis service at Creative Biolabs. (Creative Biolabs Original)

Final Deliverables: You receive a detailed report containing all quantitative glycoform data, annotated spectra, and relevant comparative analyses

Key Advantages

FAQs

  1. Q1: What is the minimum antibody amount required for a complete profile?

    A1: A comprehensive N-glycan profile can be generated from just 10-50 µg of purified antibody, ensuring minimal sample consumption, ideal for projects in early-stage cell line development.

  2. Q2: Do you provide analysis for Antibody-Drug Conjugates (ADCs)?

    A2: Yes, we offer dedicated ADC analysis workflows. Our protocols are designed to mitigate payload interference and can incorporate affinity chromatography to confirm that conjugation chemistry does not alter the Fc region's functional receptor binding.

Why Choose Us?

Our Therapeutic Antibody N-Glycan Analysis Service sets the standard by integrating bioprocess innovations with exclusive Upper-Hinge Middle-Up (UHMU) technology to reveal critical heavy-chain glycan pairing. We deliver rapid, high-fidelity data, identify trace immunogenic epitopes, and achieve this with minimal sample consumption, providing unmatched depth and efficiency for your antibody development.

Customer Reviews

"The implementation of Creative Biolabs' N-Glycan Analysis Service was pivotal for our project, enabling the definitive identification of challenging positional isomers. Their specialized Middle-Up high-resolution mass spectrometry technique clearly resolved the previously co-eluting M5 and G1F-N glycoforms, yielding the precise quantitative data essential for our application." Dr. Ar** on G.

"Leveraging Creative Biolabs' FcγRIIIa affinity chromatography service was critical to mitigating potency risks for our ADC program. The analysis confirmed that our site-specific conjugation strategy did not compromise Fc-receptor interactions, thereby verifying the preserved functionality of our dual-mechanism therapeutic." J. Bol** nd.

How to contact us?

Ready to accelerate your therapeutic antibody development with industry-leading N-glycan analysis? Connect with our PhD-level scientific team to discuss your specific project needs and receive a customized proposal. Contact us today for a consultation and a detailed quote.

Reference

  1. Duivelshof, Bastiaan L et al. "Quantitative N-Glycan Profiling of Therapeutic Monoclonal Antibodies Performed by Middle-Up Level HILIC-HRMS Analysis." Pharmaceutics vol. 13,11 1744. Distributed under an Open Access License CC BY 4.0, without modification. https://doi.org/10.3390/pharmaceutics13111744.

All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.

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