Natalizumab


Natalizumab (Tysabri) is a humanized anti–α4 integrin monoclonal antibody. It binds the α4 subunit of α4β1 and α4β7 integrins, blocking the binding to their endothelial receptors, thereby attenuating the central nervous system (CNS) inflammation. In addition, Natalizumab can further inhibit the interaction of leukocytes expressing α4-integrin with ligands in extracellular matrix and parenchymal cells, blocking further aggregation and inflammatory activity of activated immune cells. Natalizumab is approved by FDA for the treatment of multiple sclerosis and Crohn's disease. Natalizumab is specifically indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease.

Figure 1. Overall Natalizumab complex structure (Yamei Yu,2013))

Our Services

At Creative Proteomics, we provide a package service to meet different needs of Natalizumab biosimilar analysis. We have established an analytical program according to the ICH Q6B guidance, including the method setup, validation of customer specific methods and release testing to support the development of Natalizumab biosimilars. Our services include but are not limited to:

Table 1. Natalizumab biosimilar analysis service at Creative Proteomics

Characterization of the protein primary structure and secondary structure Confirming the amino acid sequence
Reconstruction of the primary structure of the entire polypeptide chain using overlapping peptides
Analysis of N- and C-terminal sequence heterogeneity
Determination of N- and O-glycosylation sites
Determine the number and location of the disulfide bond
Characterization of the glycosylation patternN-glycan mapping
O-glycan mapping
Quantification of sialic acid levels
Characterization of the physicochemical propertiesIntact protein mass determination by mass spectrometry
Charge isoforms analysis by isoelectric focusing gel electrophoresis (IEF), capillary isoelectric focusing gel electrophoresis (cIEF), and Ion-exchange chromatography (IEX)
Aggregation analysis by analytical ultracentrifugation (AUC) or size exclusion chromatography with multi angle laser light scattering (SEC-MALLS)
Binding assays and bioassays Binding measurements for alpha-4-beta-1 (VLA-4)
Alpha-4-beta-7 binding assay (flow cytometry)

Our Advantages

Creative Proteomics has long-standing experience in the analysis of different variants of Natalizumab originators and biosimilars. Our innovative approach and client management model ensure projects are managed efficiently and cost-effectively and delivered on-time. If you have any questions or specific requirements, please feel free to contact us.

Reference:
Yamei Yu, et al. How Natalizumab Binds and Antagonizes α4 Integrins. J Biol Chem. 2013 Nov 8; 288(45): 32314–32325


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Bioanalysis Services

Analysis Services

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