Generating antibodies with two or more specificities is one of the most innovative fields in therapeutic antibody development, with tremendous potential for use in creating new treatments for patients with unmet medical needs. In particular, bispecific antibody development is stimulating innovations in bioprocessing techniques from expression through upstream processing and candidate purification. Wherever possible, process-development scientists and engineers are borrowing techniques that were honed for mature monoclonal antibody (MAb) platforms, then applying those to bispecific antibody manufacturing. Nevertheless, the unique qualities of bispecifics make development of biomanufacturing strategies for them a still-emerging art form. Much remains to be done toward creating high-producing and high-yielding processes for this class of products, and challenges are likely to increase as bispecifics become even more sophisticated. In this eBook, Janice Reichert and Nick Hutchinson of The Antibody Society review the state of bispecific antibody development and describe the manufacturing-related obstacles that drug companies are facing as their candidates progress through clinical trials. Download the eBook now to learn how advances in protein-expression systems, gene-engineering platforms, and purification processes could help to improve bispecific manufacturability.
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