Even as advanced therapies and new modalities grab headlines, the monoclonal antibody (MAb) segment of the biopharmaceutical industry continues to perform, bringing needed treatments for emergent infections, rare diseases, and widespread conditions to patients who need help around the world. In fact, MAbs are at the heart of many emerging therapeutics, including bispecifics/multispecifics, antibody fragments, and antibody–drug conjugates (ADCs). But the original molecular class itself still dominates the biopharmaceutical development pipeline and the interest of biotechnology suppliers around the world. And although the vast majority of MAb therapeutics are immunoglobulin G (IgG) antibodies, the recent pandemic has brought interest in other structures as well.
This review draws from the pages of our sister publication, the open-source Taylor and Francis journal mAbs, to assess the state of the art in antibody design and engineering, developability assessment, assay technologies and characterization, biomanufacturing, and drug-product formulation. Informatics and computational tools are changing the way many of those activities proceed, helping biopharmaceutical companies speed up both product and process development by navigating the sea of information now available after decades of MAb success.
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