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Biological Stealth Bombers: Potency, Regulatory, and Bioprocessing Concerns of Antibody–Drug Conjugates

Bio Process International

Seven years ago, the US Food and Drug Administration (FDA) approved the first product in a new class of biologics: antibody–drug conjugates (ADCs). The idea for these products already had been hatched a decade earlier when the promising field of antibody research — touting such molecules as “magic bullets” — had faltered, specifically against oncology-related indications. The early crop of anticancer monoclonal antibodies (MAbs) proved to have only limited efficacy, and interest in developing antibodies as therapeutic agents against cancer had faded. Two different biotechnologists simultaneously suggested that antibodies could be much more effective against cancer — if you could arm them with a chemical warhead — capable of triggering apoptosis in tumor cells (1). They hypothesized that this combination of antibody and small molecule could finally turn laboratory-produced molecules into “magic bullets”.

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