A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
H-Big Online, Description, Chemistry, Ingredients - Hepatitis B Immune Globulin (Human)
H-Big Online, Description, Chemistry, Ingredients - Hepatitis B Immune Globulin (Human)
DESCRIPTION
Hepatitis B Immune Globulin (Human), Nabi-HBTM,
is a sterile solution of immunoglobulin (5±1% protein) containing antibodies
to hepatitis B surface antigen (anti-HBs). It is prepared from plasma
donated by individuals with high titers of anti-HBs. The plasma is purified
by an anion-exchange column chromatography method1,2 with two
added viral reduction steps described below. The product is formulated
in 0.075 M sodium chloride, 0.15 M glycine, and 0.01% polysorbate 80,
pH6.25. It contains no preservative and is intended for single use by
the intramuscular route only. The product appears as a clear to opalescent,
nonturbid liquid.
The manufacturing steps are designed to reduce the risk of transmission
of viral disease. The solvent/detergent treatment step, using tri-n-butyl
phosphate and Triton® X-100, is effective in inactivating known
enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV),
and human immunodeficiency virus (HIV). 3 Virus filtration,
using a Plan ova®35 nm Virus Filter, is effective in reducing
some known enveloped and non-enveloped viruses. 4The inactivation
and reduction of known enveloped and non-enveloped model viruses were
validated in laboratory studies as summarized in the following table:
Table 1 Log Reduction of Test Viruses5
|
Test Virus
|
| |
HIV |
BVD |
PRV |
Polio |
BFV |
| Model Virus: |
HIV |
HCV |
HBV |
Hepatitis A |
PVB19 |
| Envelope/Genome: |
yes/RNA |
yes/RNA |
yes/DNA |
no/RNA |
no/DNA |
| Manufacturing Step |
|
|
|
|
|
| dextran sulfate |
NT |
NT |
NT |
3.32 |
<1 |
| anion-exchange |
NT |
NT |
NT |
>3.52 |
>5.34 |
| solvent/detergent |
>4.67 |
>7.43 |
>5.26 |
2.7 |
>5.81 |
| virus filtration |
>6.02 |
>7.30 |
>677 |
4.25 |
>4.97 |
| BVD = Bovine Viral Diarrhea |
PRV = Pseudorabies Virus |
Polio = Poliovirus |
| BPV= Bovine Panvovirus |
PVB19= Parvovirus B19 |
NT= not tested |
The product potency is expressed in international units (IU) by comparison
to the World Health Organization (WHO) standard. Each vial contains greater
than 312 IU/mL anti-HBs. The potency of each vial of Nabi-HBTM
exceeds the potency of anti-HBs in a U.S. reference hepatitis B immune
globulin (FDA). The U.S. reference has been tested by Nabi®
against the WHO standard and found to be equal to 208 IU/mL.
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