An Integrated Approach to De-Risking Bispecific Antibody Development
About this webinar
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 characterize 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 characterization 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 localized a clipping site and fed that insight back to process development to improve purity, how systematic process development roughly doubled titer to 10+ 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
- 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
- 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 characterization and drug product development can identify risks earlier
- Bispecific case-study outcomes including approximately 2× titer improvement to 6 to 10+ g/L, greater than 99% drug-substance purity, definitive impurity characterization 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
Featured Speakers
Amit Jogi, PhD
Amit Jogi, PhD, is Head of CDMO Biologics at Aurigene Pharmaceutical Services Ltd (APSL), a wholly owned subsidiary of Dr. Reddy’s Laboratories, where he leads the company’s integrated biologics platform from cell line development through process and drug product development to GMP manufacturing.
A bioprocess technology professional with more than 20 years of varied, increasing-responsibility experience across biotherapeutics, contract research and manufacturing, technology transfer and process development, he is a result-oriented leader who has directed cross-functional teams across departmental and organizational levels and partnered directly with internal and external customers on both scientific and business fronts. He has a proven ability to design and execute on-time, on-budget large-molecule development programs for proteins and monoclonal antibodies and today advances complex modalities such as bispecific antibodies from early development into clinical and commercial supply. He holds a PhD in Microbiology from Bhavnagar University.
Partner for this event
Aurigene Pharmaceutical Services Ltd
Aurigene Pharmaceutical Services Ltd (APSL), a wholly owned subsidiary of Dr. Reddy’s Laboratories, is an end-to-end integrated CRDMO partner for biologics, spanning discovery, development, and commercial manufacturing. With more than 25 years of biologics heritage, six commercialized biologics supplied across regulated markets, and 900+ scientists, APSL offers a single, accountable platform from cell line development through upstream and downstream process development, analytical and formulation development, drug substance manufacturing, and sterile fill-finish. Its cGMP network includes USFDA-inspected facilities with 20KL+ installed bioreactor capacity and a 100% PPQ success rate over the past four years, with successful inspections by the USFDA, EMA, MHRA, ANVISA, and MFDS. With deep bispecific experience, including programs advanced from stable pool to IND and into the clinic, APSL helps sponsors de-risk complex biologics from concept to commercial.