Greater than 97.0% as determined by:
(a) Analysis by RP-HPLC.
(b) Analysis by SDS-PAGE.
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Hepatitis B virus (HBV) is a significant global health concern, causing a spectrum of liver diseases, including chronic infections that can lead to life-threatening conditions such as hepatocellular carcinoma (HCC) and liver cirrhosis . The virus is composed of viral nucleic acid encapsulated within a core particle, enveloped by three distinct virus-coded surface proteins: preS1, preS2, and S .
The hepatitis B surface antigen (HBsAg) is a protein on the surface of the hepatitis B virus. It is the primary component of the hepatitis B vaccine and is used to detect infection with the virus. The HBsAg is crucial for the virus’s ability to infect liver cells and is a target for the immune response .
The preS1 region of the hepatitis B surface antigen is essential for viral assembly and plays a major role in mediating virus attachment and entry into hepatocytes . The preS1 protein is a part of the larger HBsAg and is known for its immunogenic properties, making it a valuable component in vaccine development .
Recombinant hepatitis B surface antigen, preS1, is produced using recombinant DNA technology. This involves inserting the gene that codes for the preS1 protein into a host cell, which then produces the protein. This recombinant protein can be used in vaccines to elicit an immune response against HBV .
The development of vaccines containing the preS1 antigen has shown promising results. For instance, the Sci-B-Vac™ vaccine, which includes HBsAg as well as preS1 and preS2 antigens, has demonstrated enhanced immunogenicity compared to vaccines containing only the S antigen . Studies have shown that recognition of several preS1 epitopes is accompanied by a more pronounced antibody response to the S-gene-derived protein in healthy individuals .