An Integrated Approach to De-Risking Bispecific Antibody Development

Bispecific antibodies are among the most promising and most demanding modalities in biologics today. Their dual-targeting architecture introduces molecular complexity that monoclonal antibody platforms were never designed to handle: chain mispairing, homodimers, heavy-chain clipping, aggregation and the need to confirm that both arms engage their intended targets. This webinar will explore how an integrated development approach can help identify and address these risks earlier across the CMC program.

This molecular complexity translates into real development challenges, including low and inconsistent titers from stable pools, difficult impurity clearance, complex multi-step purification, formulation instability at the concentrations needed for patient-friendly delivery and analytical methods that must resolve and characterise closely related species before batch release. Tackled in isolation, each of these problems tends to surface late, forcing rework, comparability studies and timeline delays.

Drawing on bispecific case studies, this webinar will cover how connecting cell line, upstream and downstream process development, analytical characterisation, and drug product development within a shared development framework can de-risk each stage by allowing findings to inform decisions across the program. Case examples will demonstrate how analytical work localised a clipping site and fed that insight back to process development to improve purity, how systematic process development roughly doubled titer to 6 g/L while halving resin cost and how parallel formulation work delivered a stable drug product approximately 40% faster than the industry average.

The session will also examine how maintaining process knowledge from stable pool development through GMP supply and technology transfer can support comparability, reduce rework and strengthen the CMC development strategy.
Register for this webinar to learn how bispecific antibodies can be developed through an integrated approach that reduces rework, protects timelines and strengthens CMC development.

Who Should Attend
This webinar will appeal to professionals developing bispecific and other complex biologics, including:

• CMC leads, Program and Project Managers at biotech and pharma
• Process Development Scientists (upstream & downstream) and Cell Line Development
• Analytical and Bioanalytical Development Scientists
• Formulation and Drug Product Development Scientists
• Heads of Biologics, Technical Operations, External Manufacturing and Outsourcing leaders evaluating CDMO partners for tech-transfer and clinical-supply decisions

What You Will Learn
Attendees will gain insight into:

• The molecular and CMC challenges that make bispecific antibodies more complex to develop, including chain mispairing, clipping, impurity clearance and high-concentration stability
• How connecting cell line, upstream and downstream process development, analytical characterisation, and drug product development can identify risks earlier
• Bispecific case-study outcomes including approximately 2× titer improvement to 6 g/L, greater than 99% drug-substance purity, definitive impurity characterisation and accelerated formulation development
• How preserving process knowledge through scale-up and technology transfer can strengthen comparability and shorten the path from stable pool to GMP clinical supply

Register free on Xtalks:
https://xtalks.com/webinars/an-integrated-approach-to-de-risking-bispecific-antibody-development/