Pharmaceutical
product: Human Immunoglobulins
Human immunoglobulins are preparations of the
immunoglobulins mainly IgG present in human blood.
Normal immunoglobulin has relatively low titres of
antibodies. It is prepared from pools of plasma obtained from not fewer than a
thousand individuals.
Specific immunoglobulins have a high titre of
antibodies particularly. They are prepared from smaller pools of plasma
obtained from individuals, who have suffered recent infections or who have
undergone recent immunization and they have a high titre of particular
antibody.
Each contribution of plasma to a pool is tested for
the presence of - Hepatitis B antigen, antibodies to Human immunodeficiency
virus (HIV 1& 2), and antibodies to Hepatitis C virus.
These are tested to exclude from a pool because any
plasma may be capable of transmitting injection from donor to recipient.
Process
of Immunoglobulins preparation:
The immunoglobulins are obtained by fractionation
methods based on ethanol precipitation in the cold with regulation of protein
concentration, pH and ionic strength.
The immunoglobulins are presented as freeze - dried or
liquid preparations at a concentration that is 10 to 20 times than that in
plasma.
Glycine is used as a stabilizer and thiomersal as a
preservative.
The
potency test of Immunoglobulins:
The potency tests of immunoglobulins consist of
neutralization tests that parallel those used for the potency assay of
immunosera.
In some cases of immunoglobulins, the asssays are made
in vitro.
For
safety and sterility tests -
a) total protein is determined by nitrogen
estimations.
b) the protein composition is determined by cellulose
acetate electrophoresis and molecular size is determined by liquid
chromatography.
The precipitin test is done to exclude immunoglobulins
from other species.
Immunoglobulin
used in the prevention and treatment of infections in human:
Immunoglobulin
|
Potency
assay method
|
Potency
requirements
|
Hepatitis
B
|
Radioimmuno
assay or enzymeimmuno assay
|
not
less than 100 IU per ml
|
Measles
|
Neutralization
of the infectivity of measles virus for cell cultures
|
not
less than 50 IU per ml
|
Rabies
|
Neutralization
of the infectivity of rabies virus for mice
|
not
less than 150 IU per ml
|
Tetanus
|
Neutralization
of the paralytic effect of tetanus toxin in mice
|
not
less than 50 IU per ml
|
Varicella
Zoster
|
ELISA
in paralleled with a standard Varicella Zoster immunoglobulin
|
not
less than 100 IU per ml
|
The Daily Youth- tdy24.com Presents
"
Pharmaceutical product: Human
Immunoglobulins"
Written By
Sadia
Akhtar
Student of Department of Microbiology
Jagannath University.
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