Building a BsAb CMC Playbook: Decision Frameworks, Risks, and Readiness

Bispecifics bring CMC hurdles generic platforms can't solve. Learn a practical framework to de-risk scale-up and speed your path to launch.

Register Free: https://www.pharmtech.com/pt_w/BsAb-CMC-Playbook

Event Overview:

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, as well as standardized, 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.

Key Learning Objectives:

In this webinar you will learn about:

• How to recognize BsAb-specific CMC risks and their impact
• The use of predict-first bioinformatics (pI, hydrophobicity, liabilities) for platform fit
• Creating a decision framework/readiness checklist for scale-up and IND entry
• Planning flexible scaling and tech transfer from development to launch

Who Should Attend:

• Pharmaceutical manufacturing
• Large biotech, spinouts
• Anyone with CMC/late phase or procurement in their titles
• Technical directors and above
• CSOs
• Heads of science and above
• Consultants

Speakers:

Jonathan Haigh
Senior Vice President, Head of UK Sites
FUJIFILM Biotechnologies

Jonathan Haigh has been active in the biopharmaceutical industry for 20 years, working in both the life science technology vendor and end-user sectors, holding positions in both the US and UK. He completed a doctorate in antibody purification from the University of Cambridge and an MBA from Durham University Business School. Haigh has fulfilled a number of global technical, management, and leadership roles encompassing biopharmaceutical innovation, process development, GMP operations, and merger & acquisition activities. Haigh has worked for FUJIFILM Biotechnologies for the last 14 years in roles of increasing responsibility. He previously acted as vice president of process development, leading a team of over 350 process scientists and engineers across mammalian, microbial, and advanced therapy modalities. He currently holds the role of senior vice president, head of UK sites, leading all aspects of the business and growth strategy across 3 UK sites. Haigh holds a number of patents and publications pertinent to the bioprocessing field.

Register Free: https://www.pharmtech.com/pt_w/BsAb-CMC-Playbook