monoklonalnego

Monoclonal describes products or substances derived from a single cell clone. In immunology, monoclonal antibodies are antibodies produced by one clone of B cells, resulting in uniform affinity and specificity for a single epitope.

Most monoclonal antibodies are produced using hybridoma technology. In this method, an animal is immunized with an antigen; B cells producing the desired antibody are fused with myeloma cells to create immortal hybridomas. These cells are screened and cloned to yield a stable line that secretes a single monoclonal antibody. Modern methods based on recombinant DNA enable humanization or creation of fully human antibodies to reduce immunogenicity, and alternatives such as phage display, transgenic animals, or single-cell cloning further expand the repertoire.

Applications are widespread in medicine, research, and diagnostics. Therapeutic monoclonal antibodies target cancer cells, autoimmune disorders, and infectious diseases. They are used diagnostically in assays and immunohistochemistry, and as research tools for protein detection, purification, and cell sorting. Examples include rituximab and trastuzumab in cancer therapy.

Advantages include high specificity, consistent production, and the potential for tailored therapies. Limitations include potential immunogenic reactions to non-human components, high manufacturing costs, and the emergence of resistance in target cells. Safety considerations require rigorous preclinical and clinical evaluation, controlled production, and ongoing monitoring after approval.

Regulatory agencies such as the FDA and EMA assess monoclonal antibodies for efficacy and safety before market authorization, with ongoing pharmacovigilance post-approval. The term can also refer to any monoclonal product derived from a single cell lineage, not limited to antibodies.