HBs antigen in human plasma fractions

Area of Science:

• Biochemistry
• Immunology
• Hepatology

Background:

• Hepatitis B virus (HBV) infection poses a significant global health challenge.
• Hepatitis B surface antigen (HBsAg) is a key marker for HBV infection and is present in human plasma.
• Plasma-derived therapeutic products require rigorous purification to eliminate infectious agents like HBsAg.

Purpose of the Study:

• To develop and validate a scalable technique for purifying albumin from human plasma.
• To effectively remove Hepatitis B surface antigen (HBsAg) from albumin fractions.
• To ensure the safety of albumin products for therapeutic use.

Main Methods:

• Modified Cohn ethanol fractionation of human plasma.
• Detection of HBsAg using counterelectrophoresis and radioimmunological assays.
• Application of a novel albumin purification technique on an industrial scale.

Main Results:

• All plasma fractions, except highly purified albumin, contained HBsAg in variable amounts.
• The proposed purification technique successfully removed HBsAg from albumin fractions.
• Even plasma with high HBsAg titers (1/64) yielded undetectable levels of antigen in the purified albumin.

Conclusions:

• A scalable industrial method for albumin purification effectively eliminates HBsAg.
• This technique enhances the safety of plasma-derived albumin for therapeutic applications.
• The purification process ensures the absence of HBsAg, even from highly contaminated plasma sources.