As pressure to reach critical development milestones faster continues to grow, sponsors are seeking new ways to accelerate biologics programs without compromising product quality, manufacturability, or future scalability.
Accelerating Bispecifics, Fc-Fusions and High-Concentration Biologics to the Clinic
In this on-demand webinar, our experts explore newly expanded accelerated DNA-to-IND pathways designed to support not only monoclonal antibodies, but also bispecifics, Fc-fusions, and high-concentration biologics. Through technical data, case studies, and practical development experience, viewers will gain insight into how advances in expression technologies, integrated CMC strategies, and streamlined execution can help reduce timelines while supporting robust program progression.
The session examines how sponsors can select the right accelerated pathway for their molecule, understand the scientific and operational enablers behind these timelines, and evaluate how early development decisions can influence both IND readiness and long-term development success.
What You'll Learn
- How accelerated DNA-to-IND pathways are expanding beyond traditional mAbs and standard-concentration formulations, and which pathway may be best suited for your molecule.
- How advances in expression technologies, downstream processing, and formulation development, combined with integrated CMC strategies and streamlined execution, are helping reduce timelines while supporting manufacturability, quality, and scalability.
- How early development decisions can influence both IND readiness and long-term program success, including the role of platform technologies and lifecycle-minded development planning.
