The commercial manufacturing success of monoclonal antibodies (MAbs) has become a touchstone of the biopharmaceutical industry. MAbs are so well established that they often are referred to as “traditional” biologics, and well-known MAb processing methods have become a model for processing of other “advanced” or “emerging” therapies. But MAb processing continues to advance as biomanufacturers seek ways to improve efficiencies, lower costs, and (most recently) increase sustainability of facilities. Drug makers are particularly interested in strategies for MAb process intensification. In the biopharmaceutical industry, intensification historically has been synonymous with implementation of perfusion-mode bioreactor systems. But as this eBook shows, MAb process intensification has expanded to involve all bioprocess unit operations — and even entire production facilities. Herein, BPI’s managing editor reports on her discussions with several industry experts about new approaches to intensification. The contributors call attention to several drivers for current intensification efforts. They also describe regulatory supports for manufacturing innovations, advances in protein expression systems (and their implications for intensification efforts), considerations for multicolumn chromatography and other downstream unit operations, and requirements for the analytics that are needed to monitor and control new processes.
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