Factor VIII


Factor VIII is a heavily glycosylated heterodimeric plasma protein consisting of a heavy (domains A1-A2-B) and light chain (domains A3-C1-C2) and is mainly synthesized in hepatocytes, but also in endothelial cells, kidneys and lymphatic tissue. Moreover, factor VIII is an essential blood coagulation protein (2332 amino acids, molecular weight of 293 kDa) present in the bloodstream in association with von Willebrand factor (vWF) in a non-covalent complex. And the vWF protects factor VIII from premature proteolysis and transfers it to sites of endothelial injury. And the active form of factor VIII can be given to hemophiliacs to restore hemostasis, concentrated from donated blood plasma, or alternatively recombinant FVIIa. Antibody formation to factor VIII can also be a major concern for patients receiving therapy against bleeding.

Figure1. The 3D structure of Factor VIII (Ngo, J.C, et al. 2008)

Factor VIII Analysis at Creative Proteomics

At Creative Proteomics, we have long-standing experience to support the development of the factor VIII biosimilars. With our professional platform, Creative Proteomics provides services to characterize factor VIII biosimilars in line with ICH Q6B.

Table1. Factor VIII biosimilars analysis services at Creative Proteomics

Quantity and extinction coefficient
  • Determination of protein content
  • Amino acid composition
  • Determination of extinction coefficient
Structural characterization and confirmation– amino acid sequence
  • Peptide mapping
  • Deamidation level
  • Methionine oxidation level
  • Tyrosine sulfation level
  • Disulfide bridge analysis
  • N/C terminal sequencing
  • Total molecular weight of each subunit
Glycosylation analysis
  • Monosaccharide composition
  • Sialic acid content
  • N- and O-Glycan mapping
  • Linkage analysis
  • N- and O-Glycosylation site determination
Physicochemical properties
  • Isoform pattern (IEF)
  • Liquid chromatographic pattern
  • Spectroscopic profiles
  • Spectroscopic profiles
  • Aggregation

To deliver consistent and high-quality data with cost-efficiency, Creative Proteomics has experienced scientists and advanced techniques for factor VIII analysis, including but not limited to:

Our Advantages

Creative Proteomics has professional experts to help you design the best strategies for factor VIII biosimilars analysis. Based on professional knowledge and experienced staff, Creative Proteomics provides a wide range of information about Factor VIII. If you have any questions or specific needs, please do not hesitate to contact us.

References:
1. Mazurkiewicz-Pisarek A, et al. The factor VIII protein and its function. Acta Biochim Pol. 2016, 63(1):11-16.
2. Ngo, J.C, et al. Crystal structure of human factor VIII: implications for the formation of the factor IXa-factor VIIIa complex. Structure. 2008; 4:597-606.


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