Purification of severe acute respiratory syndrome hyperimmune globulins for intravenous injection from convalescent plasma.
BACKGROUND
Severe acute respiratory syndrome (SARS) is a new infectious disease caused by the SARS virus. Current first-line treatments are experimental, and their effectiveness remains open to question. For more effective treatment and prevention of SARS, human SARS hyperimmune globulins for intravenous (IV) injection were purified in this study.


METHODS
A combination of cold ethanol precipitation and ion-exchange chromatography was used to process pooled SARS convalescent plasma samples. Virus inactivation and removal approaches were taken to ensure safety.


RESULTS
The purified hyperimmune globulins were formulated as a 5 percent solution, with an antibody titer specifically against the SARS virus of 1:83, 1:1600, and 1:200, as determined by enzyme-linked immunosorbent assay, immunofluorescence assay, and neutralizing antibody test, respectively. The purity of the SARS hyperimmune globulins was 99.0 percent, and the monomer and dimer content was 100 percent. Other variables analyzed met the Chinese Requirements of Biologics for IV immune globulin. The SARS hyperimmune globulins prepared were subsequently approved for clinical evaluation by the Chinese National Institute for the Control of Pharmaceutical & Biological Products.


CONCLUSIONS
IV-injectable, purified, and concentrated human SARS hyperimmune globulins were prepared from pooled convalescent plasma samples, which are ready to be further evaluated.
Zhang
Zhan
Z
Shenzhen Weiwu Guangming Biological Products Co. Ltd., Guangdong, PR China.
Xie
Yi-Wu
YW
Hong
Jiling
J
Zhang
Xin
X
Kwok
Sui Yi
SY
Huang
Xiaowu
X
Wong
Sai Wah
SW
Wong
Bing-Lou
BL
D000914:Antibodies, Viral / Q000097:blood; D003289:Convalescence; D019281:Dimerization; D004797:Enzyme-Linked Immunosorbent Assay; D019084:Fluorescent Antibody Technique, Indirect; D005916:Globulins / Q000737:chemistry / Q000302:isolation & purification*; D006801:Humans; D007275:Injections, Intravenous; D009500:Neutralization Tests; D010949:Plasma / Q000276:immunology*; D045473:Severe acute respiratory syndrome-related coronavirus / Q000276:immunology; D045169:Severe Acute Respiratory Syndrome / Q000097:blood* / Q000276:immunology* / Q000517:prevention & control*
D000914:Antibodies, Viral; D005916:Globulins