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Protein and Water
Plasma, Red Cells, White Cells and Platelets
ADMA optimized IG manufacturing process to include validation for all intermediate fractions, maximizing revenue from each L of plasma
Human immune globulin is composed of antibodies—Y-shaped proteins produced by B-cells that are used by the body’s immune system to identify and neutralize foreign objects such as bacteria and viruses. IVIG is immune globulin purified from plasma by a manufacturing process called fractionation and administered intravenously to patients.
Standard immune globulins are manufactured using normal source plasma.
Manufactured using plasma obtained from donors who have elevated amounts (high titers) of specific antibodies against a targeted pathogen.
Additionally, IVIG is also used as therapy in a variety of other diseases that do not involve primary or secondary immune deficiencies, such as multiple sclerosis, skin diseases, and asthma. These latter uses are referred to as “off-label” or evidence-based uses because the FDA has not approved their use in these indications and promotion of such uses is not permitted by FDA unless approved by the agency.
The type of plasma used in immune globulin manufacturing can determine the level of antibody to specific pathogens.6,7
Once plasma is collected from donors, it may be analyzed to identify certain titers – a measure of concentration – for specific antibodies to different infectious diseases.
ADMA BioCenters is an FDA-licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases.Click here to visit ADMA BioCenters’ website
1. Nicholson LB. The immune system. Essays Biochem. 2016;60(3):275-301.
2. Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: A review of evidence. J Allergy Clin Immunol. 2017;139(3S):S1-S46.
3. Centers for Disease Control and Prevention. Understanding how vaccines work. https://www.cdc.gov/vaccines/hcp/conversations/downloads/vacsafe-understand-color-office.pdf.
4. Centers for Disease Control and Prevention Vaccines & immunizations. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm.
5. Winters JL. Plasma exchange: concepts, mechanisms, and an overview of the American Society for Apheresis guidelines. Hematology Am Soc Hematol Educ Program. 2012;2012:7-12. doi:10.1182/asheducation-2012.1.7.
6. Barahona Afonso AF, João CM. The production processes and biological effects of intravenous immunoglobulin. Biomolecules. 2016;6(1):15. Published 2016 Mar 9.
7. Orange JS, Du W, Falsey AR. Therapeutic immunoglobulin selected for high antibody titer to RSV also contains high antibody titers to other respiratory viruses. Front Immunol. 2015;6,431.