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Characterization of recombinant hepatitis B surface antigen using surface plasmon resonance
J S Tung1, J Gimenez, C T Przysiecki
1Merck Research Laboratories, Rahway, New Jersey 07065, USA. jwusheng_tung@merck.com
Journal of Pharmaceutical Sciences
|February 7, 1998
Summary
This study shows how to analyze hepatitis B surface antigen (HBsAg) particles in vaccines. Surface plasmon resonance (SPR) effectively characterizes these particles and their epitopes.
Area of Science:
- Biochemistry
- Immunology
- Vaccine Development
Background:
- Hepatitis B vaccines contain recombinant hepatitis B surface antigen (rHBsAg) particles.
- Characterizing rHBsAg is crucial for vaccine quality control.
Purpose of the Study:
- To characterize rHBsAg particles in hepatitis B vaccines.
- To compare the consistency of antigenic epitopes across different rHBsAg batches.
- To evaluate the impact of epitope alterations on antibody binding.
Main Methods:
- Utilized surface plasmon resonance (SPR) on a BIAcore system.
- Employed two commercial monoclonal antibodies to probe epitopes on rHBsAg.
- Assessed antibody avidity across various rHBsAg batches and chemically modified variants.
Main Results:
- Identified distinct epitopes recognized by monoclonal antibodies on rHBsAg.
- Demonstrated consistency of these epitopes in different rHBsAg batches.
- Showcased that chemical modifications altering epitopes directly affected antibody avidity.
Conclusions:
- SPR provides an efficient method for characterizing rHBsAg particles.
- This approach ensures the quality and consistency of hepatitis B vaccine products.
- The study offers a novel way to assess vaccine antigen integrity.