Journal of Analytical & Bioanalytical Techniques
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The first publication on intravenous immunoglobulin (IVIG) administration
for children with immune thrombocytopenia ITP (Imbach et al., The Lancet
1981;1:1228-1231) evoked targeted immunomodulation in patients with
inflammatory and autoimmune disorders. We update the development of the
immunomodulatory effects of IVIG over the last 30 years. The biologic, human IVIG
is extracted from the pooled plasma of 10�000 � 60�000 blood or plasma donations.
The safety of IVIG is controlled by ongoing careful selection and deferral of donors,
by testing and validation of donated blood and plasma as well during the steps of
production including the purification process. The key observation/discovery was
made in a boy with severe bleeding immune of ITP. Following administration of
IVIG the boy�s platelet counts started to increase and in a subsequent pilot study
the same phenomenon was observed of 12 consecutive children with ITP. Since
then, there have been controlled clinical trials of IVIG in patients with ITP as well
as in other inflammatory or autoimmune disorders. Examples of documented
immunomodulation are today: in hematology: graft versus host disease, allograft
recipients, autoimmune lypmphoproliferative syndrome and others, in neurology:
Guillain-Barr� syndrome, dermatomyositis, myasthenia gravis, multifocal motor
neuropathy, remitting-relapsing multiple sclerosis and others, in dermatology:
autoimmune mucocutaneous blistering diseases, pemphigus, Stevens-Johnson
syndrome and others. Extensive studies on the mechanisms of action of IVIG have
documented the immunomodulatory interaction in the disturbed immune response
in these patients, although the mechanisms of actions remain far from being clear.
Today, the clinical efficacy of IVIG has resulted in high demand for the product.
The peer reviewed scientific, original articles on �IVIG� (see PubMed) listed at total
of 32�251 publications until 2010. The worldwide annual use of IVIG increased
remarkably, from 300 kg to 70,000 kg over the last 30 years. Thus, the human
derived product IVIG challenged therapeutic approaches from immunosuppression
to biologic immunomodulation in many inflammatory and autoimmune disorders.
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