In addition, the ENBBSs long-term goal includes the manufacturing of immunoglobulins and other products derived from human plasma. illegal routes and make the product readily accessible, a small-scale and low-cost approach such as a mini-pool plasma fractionation technique could be implemented to locally purify and prepare IVIG using plasma collected through the national blood donation program. Keywords:Convalescent sera, immunoglobulin, immunotherapy, IVIG, plasma fractionation == Introduction == Immunoglobulins (IGs) or antibodies are glycoproteins that are produced by B cells in response to specific antigenic stimuli such as bacteria, viruses, fungi, parasites, cellular antigens, chemicals, and synthetic substances.1Based on differences in the amino acid sequence, five major antibody isotypes have been identified: IgA, IgD, IgE, IgG, and IgM.2In serum, the IgG isotype comprises 75% to 80% of the antibodies2and it is the only immunoglobulin that crosses the placentae and thus the most abundant isotype in neonates.3 Disorders of IGs can result from intrinsic genetic defects, secondary to malnutrition and chronic diseases such as cancer, autoimmune, dermatologic, and infectious diseases. The most common types of antibody disorders, worldwide, are X-linked agammaglobulinemia, transient SDZ 220-581 hypogammaglobulinemia of new-borns, selective immunoglobulin immunodeficiencies, super IgM syndrome, and common variable immunodeficiency disorder.4In such humoral immune disorders, intravenous immunoglobulin G (IVIG) replacement therapy is the treatment of choice.5The composition of IVIG preparations closely relates to the IGs found in normal human plasma and it contains concentrated IgG immunoglobulins pooled from the plasma of thousands of healthy blood donors. The therapeutic applications of IVIG go beyond antibody replacement therapy in patients with antibody deficiency. Ever since its inception, the number of inflammatory and autoimmune diseases for which IVIG is used has been expanding enormously. These diverse disorders range from transplant rejection to blistering skin diseases and neurologic diseases. IVIG is now widely accepted for use in patients with multiple other diseases including, but not limited to, Guillain-Barr syndrome, multiple myeloma, myasthenia gravis, acquired factor VIII inhibitor syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, autoimmune neutropenia, post-transfusion purpura, and polymyositis or dermatomyositis.6,7Unlike subcutaneous IGs, treatment with IVIG is carried out every 3 to 4 4 weeks with rare local infusion site reactions. Adverse events associated with IVIG treatment are commonly systemic and can be either moderate or moderate and rarely patients may develop severe reactions.8These adverse events are commonly seen in treatment nave patients, especially during their first infusion, and the reactions usually subside along with treatment. These symptoms include moderate to moderate headache, nausea, fever, fatigue, and flu-like symptoms.9 Historical precedents also showed the safety and efficacy of IVIG therapy as an anti-infective agent in a growing array of diseases including the West African Ebola epidemic,10novel influenza A virus pandemic,11severe acute respiratory syndrome of coronavirus 1 (SARS-CoV-1)12and Spanish Flu pandemic.13In the current SARS-CoV-2 pandemic, infusion of human convalescent sera preparations obtained from individuals who have recovered from the infection has been shown as a reliable treatment approach in critically ill patients.14As such, the clinical importance of IGs as a source SDZ 220-581 of neutralizing antibodies for specific pathogens can never CR2 be overemphasized. In addition, biotherapeutics such as monoclonal antibodies and recombinant proteins offer some degree of clinical advantage in terms of safety, efficacy, and convenience over the standard of care and are pivotal components of modern medicine. However, these treatment options are generally not readily available in low- and middle-income countries (LMICs) including Ethiopia, partly due to their higher costs compared to available conventional alternatives. Another reason could be attributed to health system challenges that create a lack of information in identifying patients who could otherwise benefit from biotherapeutics. For example, some promising and lifesaving biotherapeutics that have proven to considerably increase the overall survival of patients in high-burden conditions such as human epidermal growth factor receptor 2 positive breast cancer take a long time to be integrated into the public health systems.15-17This is one reason why a higher proportion of premature deaths from cancer is more prevalent in LMICs than in developed countries.18Therefore, as therapies are now shifting from pharmaceuticals SDZ 220-581 to monoclonal antibodies and RNA-based therapies, it is high time for LMICs to start venturing into these potentially lifesaving treatment options. Fundamentally, plasma fractionation and IVIG preparation are done.