Praiseldy Langi Sasongko

13 General Introduction Immunoglobulins Immunoglobulins (Ig) are a group of proteins found within plasma. When the technique of plasma fractionation was discovered in the 1940s, immunoglobulins were one of the subgroups that was naturally separated in the process.1,16 Biologically, Ig act as antibodies to protect against and ward off infections. Thousands of Ig are available in pooled donations of plasma donors, which makes it a rich potential for medical use.16 Since the early 2000s, intravenous immunoglobulins (IVIG) became the driver in plasma demand, growing exponentially with time for its notable uses in treating primary and secondary immune diseases and being an immunomodulatory agent for many other diseases.16 Now, it is used as a treatment option for a wide range of conditions, both “on-label” (registered, proven to be efficacious) to “off-label” (non-registered, not yet proven to be efficacious).17 Because of this, worldwide demand for plasma has skyrocketed and continues to grow18 (see Figure 1.3). Current global supply is found insufficient, and shortages often occur worldwide.18 Figure 1.3: Worldwide and European trends in immunoglobulin sales from 2000-2022 (source: MRB)19 300 250 200 150 100 50 0 2000 2003 2005 2008 2010 2013 2016 2019 2022 Worldwide

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