Objective To study the manufacturing process and the virus inactivation of variceUa-zoster immunoglobu- lin. Methods Plasma in which the antibody potency was greater than 5 IU/mL was selected for manufacturing use. By pres- sure filtration, the precipitate of component Ⅱ was obtained. After dissolution of the precipitate, it was treated by uhrafiltra- tion, viral inactivation in low pH and 20 nm nanofiltration, and then it was lyophilized, adjusted, bacteria eliminated and final- ly filled and metered. Results Product potency was greater than 50 IU/mL. All other tests were in accordance with the standards of Chinese Pharmacopoeia （2010 edition, part Ⅲ ） for human immunoglobulin. Accelerated stability test was accept- able. 20 nm nanofihration can reduce PPV viral titer above 4. Ol og. Conclusion This process is a simple method for varlcel- la-zoster immunoglobulin manufacture. The use of 20 nm nanofihration increases the safety of this product.
Chinese Journal of Blood Transfusion