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Therapeutic biologics represent a broad and complex class of medicinal products derived from biological sources, such as living cells or microorganisms, through biotechnology [1][3]. Unlike traditional small-molecule drugs, which are chemically synthesized and typically have low molecular weights, biologics are large, heterogeneous proteins or nucleic acids with intricate three-dimensional structures [4][7]. This class encompasses a wide range of products, including monoclonal antibodies, recombinant proteins, vaccines, and advanced gene or cell therapies [5][9]. Their primary clinical utility lies in their high specificity for molecular targets, such as cytokines or cell-surface receptors, allowing for the precise modulation of pathways involved in cancer, autoimmune disorders, and inflammatory diseases [3][11]. However, their complex nature presents unique challenges, including the risk of immunogenicity, where the development of anti-drug antibodies (ADAs) can neutralize therapeutic effects or lead to adverse safety outcomes like infusion-related reactions [8][12].
Therapeutic biologics function by binding with high specificity to specific molecular targets (such as cytokines, receptors, or cell-surface antigens) to neutralize soluble ligands, block signaling pathways, or recruit the immune system for cell-mediated destruction [3][11].
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