The Hidden Challenges Of ADC Manufacturing - And How To Overcome Them

Antibody–drug conjugates (ADCs) are reshaping modern oncology with their targeted precision, but they also introduce manufacturing demands far beyond conventional biologics. As more than 100 ADCs advance through clinical development, the industry faces increasing pressure to manage their unique sensitivities. These hybrid molecules—combining potent small‑molecule payloads with fragile monoclonal antibodies—are highly susceptible to variation in temperature, pressure, shear stress, and handling, making specialized processes essential.

To safeguard product integrity, manufacturers rely on single‑use systems that minimize cross‑contamination, protect operators, and enable precise monitoring of critical parameters. Filtration becomes a key control point, requiring carefully managed flow and pressure to maintain stability and prevent aggregation. Aseptic filling operations must accommodate small volumes and high potency, while integrated lyophilization ensures long‑term stability without exposing product to environmental risk. Together, these capabilities support consistent, safe, and compliant production for today’s most advanced oncology therapies.