Scalable Purification Strategies For Antibody-Drug Conjugates

Antibody-drug conjugates introduce a level of downstream complexity that challenges even well-established purification platforms. Closely related variants, aggregates, and over‑conjugated species can quickly compromise product quality if impurity profiles aren’t tightly controlled. Mixed-mode chromatography offers a powerful approach to address these challenges, enabling more selective separations where conventional methods fall short. Examine how mixed-mode strategies can be tuned to separate monomeric ADCs from high molecular weight aggregates while refining drug-to-antibody ratio distributions. A practical process development case study illustrates how adjustments to resin loading and elution conditions can improve selectivity, recovery, and robustness.

Ceramic hydroxyapatite chromatography is a scalable polishing option that supports consistent manufacturing outcomes across both biosimilar and novel ADC programs. Watch to gain actionable insights for building more reliable, reproducible ADC purification processes.