What are monoclonal antibodies and how do they work? Monoclonal antibodies, sometimes referred to as mAbs, are lab-made antibodies that are cloned from a single parent cell (hence their prefix, ‘mono-’), and they’re engineered to bind to a single foreign antigen. First, the basics: how do monoclonal antibodies work? Although we’ll focus on monoclonal antibodies in particular, the approaches and ideas explored below apply directly to other types of molecules including bispecific antibodies, multispecific antibodies, antibody fragments (fAbs), and some therapeutic proteins. This article will explore the latest insights related to these and other important questions. How can you efficiently produce a variety of therapy types in your pipeline?.How can you better standardize and intensify your process while staying flexible enough to rapidly adapt as your development pipeline evolves?.What are the risks and advantages of flexible, highly scalable single-use technologies versus fixed stainless steel installations?.At what point in the development timeline should you invest in manufacturing capacity?.Questions for building a strong monoclonal antibody strategy: Today’s innovators and established manufacturers are moving the mAb industry toward an all-new frontier, where high-throughput screening and AI-powered protein design will de-risk the developmental pipeline and increase the overall value proposition of mAb products.įor startups, mature pharma companies, and contract development and manufacturing organizations (CDMOs) alike, the key to riding this wave of innovation into an exciting and sustainable future lies in asking the right questions early, and in planning your future manufacturing network strategy around the answers. Meanwhile, as approvals of antibody therapies accelerate and new combination therapies continue to emerge, one thing is certain: mAbs are here to stay. In fact, they represented about 70% of total biopharma sales in 2019-a 50% increase in just four years. During the 35 years separating those milestone events, mAbs were established as the majority contributor to the global biologics market.
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