Solving The AOC Puzzle: Strategies For Chemistry, Manufacturing And Regulatory Success

The webinar explores the critical challenges of developing and manufacturing antibody-oligonucleotide conjugates (AOCs) — a promising class of therapeutics with the potential to treat diseases once considered untreatable. Despite their potential, AOC development posed significant scientific and regulatory complexities, including issues related to sequence fidelity, conjugation stability, and impurity management. Identifying a development partner with deep expertise in protein engineering, oligonucleotide chemistry, and bioconjugation was recognized as essential — yet often difficult.

In the session, Dr. Stephen Verespy, Scientific Leader, and Dr. Jeffrey Mocny, Vice President of Regulatory Strategy, addressed these challenges directly, offering practical solutions to overcome the chemical, technical, and regulatory hurdles inherent in AOC development.

Key learning points included:

• Understanding the chemical intricacies of integrating antibody and oligonucleotide components into viable, scalable AOCs
• Gaining practical knowledge of oligonucleotide synthesis and bioconjugation techniques
• Differentiating AOCs from ADCs based on payload complexity, impurity profiles, and analytical requirements
• Navigating regulatory expectations, with insights on impurity control, stability, immunogenicity, and defining clear target product profiles

Featured Speakers:

Dr. Stephen Verespy – Scientific Leader, Abzena

Dr Stephen Verespy earned his PhD in Chemical Biology from Virginia Commonwealth University at the Center for Drug Discovery and completed and completed postdoctoral training in Chemical Glycobiology at the University of California, San Diego. He brings extensive expertise in small molecule organic synthesis, linker design and synthesis, and bioconjugation, specifically focusing on ADCs, glycans, oligonucleotides, and peptide conjugates. Verespy currently serves as Director of the Scientific Office at Abzena, leveraging his substantial experience – including six years at a San Diego-based biotech, where he most recently led bioconjugation and chemistry initiatives.

Dr. Jeffrey Mocny – VP of Regulatory Strategy, Abzena

Dr Jeffrey C. Mocny joined Abzena in early 2022 as Scientific Lead for Product Strategy, Regulatory Strategy, Quality Management, and Product Development, based at their Bristol, PA facility. Before joining Abzena, Mocny served as Senior Vice President of Regulatory Affairs at ProEd Regulatory, a medical communications and strategy agency. With over three decades of experience in drug development and regulatory strategy, Mocny has extensive expertise guiding programs from concept to completion across biotechnology, nutraceutical, and pharmaceutical industries.