Still the largest sector of the biopharmaceutical industry, monoclonal antibodies (MAbs) have an impressive history and a bright future. Authors in this featured report address process advancements, manufacturing capacity, and MAb product development for COVID-19 and G-protein–coupled receptors. The coronavirus pandemic has challenged a typically careful and deliberate approach to MAb development and disrupted supply chains for development and manufacturing — not only for those antibodies deemed most promising a year ago, but also others that have been thrust into the spotlight as potential COVID-19 treatments. Authors in this report highlight some of those candidates as well as others with antibody–drug conjugate (ADC) potential against a “new” class of targets. Articles herein also elucidate the current state of manufacturing capacity for the MAb industry. Here you’ll find an update on the MAb landscape as this anomalous year begins to draw to a close with all too few answers to many questions that have arisen over the past several months.

Making MAbs: Bioprocess Advancements Challenge Platform Assumptions
by Cheryl Scott
Some observers might think there’s nothing new to say about MAbs; others point to antibody derivatives as a more exciting alternative. But MAbs are far from an outdated technology. With cost reductions and improvements in process efficiency, the MAb future not only is bright, but also could be amazing. Here, BPI’s cofounding senior technical editor reviews recent reports from our fellow Informa publication, the mAbs academic journal, highlighting process intensification and other advancing technologies for analysis, production, and processing. These developments may not provide a truly “disruptive” revolution in MAb development and manufacturing, but they do indicate where innovation should make a difference in the near future.
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The Therapeutic Monoclonal Antibody Product Market
by Dawn M. Ecker, Thomas J. Crawford, and Patti Seymour
Since the first commercial launch in the early 1980s, therapeutic MAbs and related products have become the dominant drug class within the biopharmaceutical market. They have been approved for treating a broad range of diseases, from those with patient populations of a few thousand or less to those afflicting hundreds of thousands and even millions of patients. With recent approvals of MAb products for infectious disease, there is even potential for MAb products to combat the coronavirus pandemic. Here, authors from BDO USA’s BioProcess Technology Group analyze the current picture and future prospects of MAb biotherapeutics around the world.
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Tracking Therapeutic Antibody Development in a Pandemic
by Nick Hutchinson
The COVID-19 pandemic has generated a significant and rapid response from scientists who aim to develop drugs and vaccines in the academic, government, and industrial sectors. Such interventions are essential to containing SARS-CoV-2, the coronavirus that causes COVID-19. To inform the scientific community and the public at large about global efforts to develop targeted therapies such as MAbs, The Antibody Society (TAS) and Chinese Antibody Society (CAS) have designed and implemented the COVID-19 Antibody Therapeutics Tracker, a freely available online database. The author interviews TAS executive director Janice Reichert (also founding editor in chief of the mAbs journal) and others about drug-discovery and technical insights gleaned from those data as well as clinical trial and regulatory aspects of pandemic MAb development.
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G-Protein–Coupled Receptors: Promising Targets for Antibody–Drug Conjugates
by Andrew C. Huang, Deling Yu, Yuqing Shen, and Yongjian Wu
G-protein–coupled receptors (GCPRs) are a “hot topic” of research and the largest group of drug targets for small-molecule drugs, but until recently have not been antibody targets. Many human physiological functions are related to the signaling pathways regulated by GPCRs, and dysfunctions of those pathways cause a number of diseases such as cancers, mental disorders, diabetes, cardiovascular diseases, and inflammatory disorders. Several different types of antibodies can target GPCR proteins: e.g., single-domain antibodies, bispecific and multispecific antibodies, and antibody–drug conjugates (ADCs). So the pharmaceutical industry’s interest is increasing for development of MAb drugs targeting GPCR molecules for treating GPCR-related diseases. The authors review how and highlight some recent developments.
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