immunoglobulinbased

Immunoglobulin-based products are therapeutics derived from antibodies or engineered antibody molecules. They include polyclonal immunoglobulins sourced from human plasma, such as intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG), as well as monoclonal antibodies (mAbs) produced by recombinant techniques. These products are designed to support, modulate, or specifically target components of the immune system.

Polyclonal products provide broad, nonspecific immune support and can neutralize a range of pathogens or autoantibodies. They are commonly used for primary antibody deficiencies and certain autoimmune conditions. Monoclonal antibodies are designed to bind a single antigen with high specificity and can block signaling pathways, recruit immune effector functions, or deliver cytotoxic activity to diseased cells. They are employed across oncology, autoimmune and inflammatory diseases, infectious diseases, and neurology.

Production and safety considerations vary by type. IVIG is derived from pooled human plasma; SCIG is similar but formulated for home administration. Monoclonal antibodies are produced in mammalian cells or other expression systems and are highly consistent in structure. Safety concerns include potential infusion reactions and, with IVIG, risks of renal impairment or thrombosis; with mAbs, infusion reactions and immunogenicity are considerations. Regulatory oversight ensures quality, purity, and clinical efficacy.

Regulation and clinical use vary by product and indication. Dosing and indication details depend on the specific immunoglobulin-based product. Ongoing research aims to expand indications, improve safety profiles, and develop newer antibody formats such as antibody-drug conjugates and bispecifics.