Pharmaceutical product: Human Immunoglobulins

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.