Abstract

To date, more than 10 antibody-drug conjugates (ADCs) have been approved by the U.S. Food and Drug Administration (FDA) and contribute to the medical community. Interestingly, all of them are manufactured using chemical conjugation techniques. This demonstrates that chemical conjugation is the primary approach to ADC manufacturing. Compared to other conjugation techniques (e.g., genetic engineering or enzymatic), chemical conjugation has the advantage of a relatively simple chemistry, manufacturing, and control (CMC) for ADC, prompting pharmaceutical companies to choose this technique for ADC projects. To better understand this advantage, this article provides an overview of established full chemical conjugation methods that have already been applied in the scale-up phase for ADC production.

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