Main Conference Day 2 (2nd September 2026)Wednesday, 2 September 2026

Antibody-drug conjugates (ADCs) combine the targeting precision of monoclonal antibodies with the potency of cytotoxic drugs. Their performance depends on purity. Product-related impurities, including high molecular weight aggregates and over-conjugated species with a high drug-to-antibody ratio (DAR), can reduce both safety and efficacy. This makes downstream control a key challenge in ADC manufacturing.

In this session, we present the purification of an emtansine biosimilar ADC using CHT™ Ceramic Hydroxyapatite chromatography media. We show how its calcium-affinity cation-exchange interaction separates monomeric ADCs from aggregates and over-conjugated species. Our process development studies achieved strong aggregate clearance and enrichment of the target DAR profile, with optimized parameters for resin loading, elution, and scale-up.

These results show that this calcium-affinity cation-exchange chromatography media offers a scalable, reproducible option for improving product quality and batch-to-batch consistency in both biosimilar and novel ADC programs.