Cetuximab is a recombinant monoclonal antibody that has been applied for various cancer treatments for many years. Biosimilar candidates for cancer therapies development is of great significance for humans. Based on first-in-class technology platforms, Creative Biolabs has made great achievements in glycoprotein investigations. We are proud to provide high-quality services in N-glycan profiling of biosimilar candidates at the most competitive cost.

Background of Cetuximab Biosimilar Candidates

Therapeutic recombinant monoclonal antibody (mAbs) drugs have emerged as a clinically important drug class, which were mainly used for cancer treatment. There are more than 30 therapeutic antibodies have been approved for clinical use. Cetuximab, a therapeutic mAb drug approved by FDA in 2009, actually is an epidermal growth factor receptor inhibitor that has been applied for clinical treatment of metastatic colorectal cancer, metastatic non-small cell lung cancer, and head and neck cancer. Recent years, studies on biosimilar candidate are increasing. The development of biosimilar candidates of cetuximab is becoming a trend mainly due to:

  • Treatment of cancers with good therapeutic effect and little or no effect
  • Lucrative targets
  • Patent protection has expired
  • The expensiveness of the production and characterization

Why N-glycan Profiling?

  • The attachment N-glycans on mAbs or glycosylation of mAbs is considered to play significant roles in many biological and therapeutic processes such as cell-cell adhesion, cell surface receptor recognition, and antibody-dependent cellular cytotoxicity.
  • A part of antibodies can’t function without glycans due to that glycans are essential for antibody binding to all Fc gamma receptors.
  • Previous antibody glycan analysis is mainly performed by the 2-aminobenzamide hydrophilic interaction liquid chromatography (HILIC) method after glycans released from antibodies, which has limited use for screening a large number of samples

Therefore, N-glycan profiling analysis of the mAbs or biosimilar candidate is becoming an increasingly critical process in antibody characterization and regulatory evaluation. Creative Biolabs has accumulated extensive experience in N-glycan profiling based on powerful technologies.

Strategy used in the new glycan analysis of antibodies Fig.1 Strategy used in the new glycan analysis of antibodies (Yang, 2016).

Creative Biolabs has successfully developed several effective strategies in comprehensive N-glycan profiling of biosimilar candidates. If you need a professional scientific research staff and a full range of services on N-glycan profiling, just feel free to contact us for more detailed information.

Reference

  1. Yang, X.Y.; et al. Ultrafast and high-throughput N-glycan analysis for monoclonal antibodies. MAbs. 2016, 8(4): 706-717.

Related Services:

  1. N- and O-linked Glycoprofiling of Ebolaviruses GP1, 2 Glycoproteins
  2. Concanavalin A-Binding Glycoproteins Profiling
  3. Cell Surface Glycoprotein Profiling
  4. oLHalpha Glycoprotein Profiling
  5. Plasma Glycoprotein Profiling
  6. Serum Glycoprotein Profiling

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