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The ADC Era: Bridging Innovation and Manufacturability for Precision Biopharmaceuticals

Antibody–drug conjugates (ADCs) are at the forefront of targeted therapy, combining the precision of monoclonal antibodies with the efficacy of cytotoxic agents, delivering highly potent treatments directly to diseased cells while limiting systemic toxicity. The promise of ADCs to transform disease treatment since their inception in the 1960s is undeniable,1 but so are the challenges for their development and manufacture.2 As their clinical impact grows, so does the need to refine development economics and efficiencies as ADCs are inherently complex, requiring specialised payload handling with high containment environments. Historically, these difficulties have translated into extended timelines, elevated costs and operational bottlenecks. As the field advances, particularly in relation to the increasing volume of ADC-based therapies reaching clinical trials and the increased requirement for large-scale manufacture, addressing bottlenecks by selecting the correct equipment for each specific step becomes increasingly important, whether through purchasing equipment for use in-house or by working with a trusted CDMO partner.

Although the first antibody-drug conjugates (ADCs) were tested on animal models in the 1960s,1 and the first ADC-based clinical trials conducted in the 1980s, the first ADC-based drug, Mylotarg (gemtuzumab ozogamicin), was only approved in the year 2000. However, Mylotarg had a rocky start; it required a black box warning to be added to the packaging a year after its first approval and was withdrawn from the US market in 2010 due to hepatotoxicity. Nevertheless, it was reintroduced in 2017 by Pfizer following further clinical trials.3 Despite this initial setback for the field, it stimulated progress in the area, with several ADC-based therapies being approved in the 2010s, including the blockbuster Adcetris (brentuximab vedotin), heralding a new dawn in the field of ADC modalities and an explosion of interest in this class of drugs.

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