Intravenous immunoglobulin (IVIG), also known as immune globulin, is a medical treatment consisting of concentrated antibodies derived from human plasma. It is administered intravenously, meaning it is delivered directly into a vein.

 

IVIG contains a mixture of different antibodies, including immunoglobulin G (IgG), which are proteins produced by the body's immune system to help fight off infections. These antibodies are purified from the plasma of thousands of healthy blood donors and then processed into a concentrated form.

 

The exact mechanism of action of IVIG is not fully understood, but it is believed to have several beneficial effects on the immune system. IVIG can provide passive immunity by temporarily supplementing the recipient's own antibodies, helping to boost their immune response. It can also modulate the immune system by interacting with various components of the immune system, such as T-cells and B-cells.

 

IVIG is used in the treatment of various medical conditions, particularly those involving immune system dysfunction. It is commonly prescribed for individuals with primary immunodeficiencies, where their immune system is impaired and unable to produce sufficient antibodies. IVIG can also be used for autoimmune disorders, where the immune system mistakenly attacks the body's own tissues, such as in diseases like immune thrombocytopenic purpura (ITP), Guillain-Barré syndrome, or Kawasaki disease.

 

The dosage and frequency of IVIG administration vary depending on the specific condition being treated. It is typically administered in a hospital or clinic setting under the supervision of healthcare professionals due to the potential for side effects, such as headache, fever, nausea, and allergic reactions. Rarely, more serious side effects like blood clots or kidney problems may occur.

 

It's important to note that IVIG should only be used under the guidance and prescription of a qualified healthcare provider. They will determine the appropriate dosage, treatment duration, and monitor the patient's response to therapy.

 

The manufacturing process of intravenous immunoglobulin (IVIG) involves several steps to ensure the purity, safety, and effectiveness of the product.

 

Here is a general overview of the manufacturing process:

 

Plasma Collection: The first step is the collection of human blood plasma, which contains antibodies. Plasma is obtained from healthy blood donors through a process called plasmapheresis. During plasmapheresis, blood is drawn from the donor, and the plasma is separated from other blood components using a specialized machine. The collected plasma is then pooled together from multiple donors to create a larger batch.

 

Screening and Testing: The collected plasma undergoes rigorous screening and testing to ensure its safety. Donor plasma is tested for infectious agents, such as viruses (e.g., HIV, hepatitis B, hepatitis C), bacteria, and other potential contaminants. Only plasma that passes the strict screening criteria is used for further processing.

 

Purification: The pooled plasma undergoes a series of purification steps to extract the immunoglobulins, particularly immunoglobulin G (IgG), from other plasma proteins. These purification steps typically involve techniques such as cold ethanol fractionation, precipitation, and chromatography. The goal is to isolate the desired antibodies and remove any impurities.

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Viral Inactivation/Removal: To enhance the safety of IVIG, additional steps are taken to inactivate or remove any potential viruses that may be present in the plasma. Methods such as solvent-detergent treatment, pasteurization, or nanofiltration can be employed to reduce viral contamination.

 

Formulation and Sterilization: The purified immunoglobulins are then formulated into a final product. This includes adding stabilizers, such as sugars or amino acids, to maintain the stability of the antibodies. The product is further filtered and undergoes a sterilization process to remove any remaining microorganisms.

 

Quality Control: Throughout the manufacturing process, extensive quality control tests are conducted to ensure the safety, potency, and consistency of the IVIG product. These tests include assessing the antibody concentration, purity, viral marker testing, and other quality parameters.

 

Packaging and Distribution: Once the IVIG product passes all quality control tests, it is packaged into vials or bags suitable for intravenous administration. The product is labeled with necessary information, including dosage, batch number, expiration date, and storage instructions. It is then distributed to healthcare facilities and pharmacies for use in patient treatment.

 

It's important to note that the manufacturing process can vary between different manufacturers and may be subject to specific regulations and guidelines set by health authorities in different countries. The process outlined above provides a general overview of the steps involved in IVIG manufacturing

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Product Description
AimaIG is Human Normal Immunoglobulin for IV use prepared from Human Plasma. Each unit of plasma is tested right from the collection point and  before starting of manufacturing process. Final product undergoes extensive testing from various protocols HBsAg, Ab-Ag HIV, anti-HCV by ELISA and for HBV-DNA, HCV-DNA, HAV-RNA, HIV-RNA, Parvovirus B19-DNA by NAT/PCR. 

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Indications

• Primary Immune Deficiency Diseases (PIDDs)

• Idiopathic Thrombocytopenic Purpura (ITP)

• Kawasaki Disease (KD)

• Guillain-Barré Syndrome (GBS)

• Chronic Lymphocytic Leukaemia (CLL)

• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Storage

• Store at 2 to 8°C

• Protect from light.

• Do not freeze.

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Shelf-life

36 months from the date of manufacture