The Path To Regulatory Approval For AOCs

By Jeffrey Mocny, Ph.D., VP of Quality and Regulatory Strategy, Abzena; and Stephen Verespy, Ph.D., Scientific Leader, Abzena

Antibody-oligonucleotide conjugates (AOCs) are an exciting frontier in precision medicine, combining antibody targeting with gene-modulating oligonucleotides to enable highly specific therapies with fewer off-target effects.

Unlike traditional ADCs, AOCs bring together two complex and chemically distinct components, requiring deep expertise in protein engineering, oligo chemistry, and bioconjugation. The challenges—ranging from maintaining sequence fidelity and conjugation stability to managing impurities—demand innovative solutions to preserve functionality, efficacy, and manufacturability.

While complex, AOCs hold transformative potential for treating hard-to-target diseases, making scientific precision and integration essential to their success.