Building a BsAb CMC Playbook: Decision Frameworks, Risks, and Readiness
Day 2 Next-Gen Bio Stage
07/10/2026 13:45 - 14:10pm
Contributors
Jonathan Haigh : Senior Vice President, Head of UK Sites, FUJIFILM Biotechnologies - FUJIFILM Biotechnologies
Early, well-informed CMC choices can reduce costs, compress timelines, and build investor confidence by de-risking scale-up and approval. Bispecific antibody formats are diverse, limiting broadly applicable platform approaches to process development and posing distinct CMC challenges (aggregation, fragmentation, homodimers, mis-paired/partially assembled species). Coupled with typically lower titers, these factors drive variability, complicate purification and analytics, and raise costs.
This session presents a practical framework: a predict-first bioinformatics review (pI, surface hydrophobicity, chemical liabilities) to assess platform fit and guide workflow selection; upstream chain-balancing during cell line development to promote correct assembly; and downstream high-throughput screening to select charge- or affinity-led purification resolving heterodimers, homodimers, and HMW species, with supporting analytics.
Case studies show gains in purity, yield, and reproducibility, and standardised, scalable unit operations that enable efficient translation to the clinic. With these variables, flexibility in scale can aid a successful path from development to commercial launch.