Bridging Innovation & Clinical Reality In ADC And AOC Development

If you're developing an antibody-drug conjugate (ADC) or antibody-oligonucleotide conjugate (AOC), the science may be the easiest part. The harder work is building a development program that actually holds up under clinical and regulatory scrutiny.

Regulatory and bioconjugation specialists Jeffrey Mocny and Nicolas Camper lay out where programs most often run into trouble, and it's almost always earlier than developers expect. ADCs now have more than a dozen FDA approvals behind them, so the regulatory path is better defined, but that doesn't mean the manufacturing is simple. Newer conjugation strategies are adding processing steps and specialist chemistries that compress the margin for error. AOCs are in a different position altogether: earlier in development, with more open questions around analytical characterization, formulation, and what regulators will ultimately expect.

What both modalities share is the same core pressure point: demonstrating control over product quality and manufacturing consistency before clinical entry. Chemistry, manufacturing, and controls (CMC) gaps that feel manageable in early development have a way of becoming very expensive later. The case here is for treating scalability and analytical strategy as design inputs, not afterthoughts.

Access the full analysis to pressure-test your current development assumptions before they become program liabilities.