Leveraging Stable Pool Material To Expedite The Path To IND

Regulatory approval marks a critical hurdle in biopharmaceutical development, and with an influx of antibody-based therapeutics facing fierce competition, streamlining the path to Investigational New Drug (IND) submission is paramount. Critical to reducing these timelines is having an integrated approach to development, coordinating overlapping activities to obtain IND enabling data in as short a timeframe as possible. This webinar explores how an integrated approach to Cell Line Development (CLD) can expedite this process while maintaining product quality.

A robust CLD strategy prioritizes early developability and manufacturability assessments of both cell lines and molecules to mitigate risks and delays. Review the efficacy of fast stable pools in generating purified product from candidate panels at an early stage. This access facilitates parallel non-clinical investigations, substantially compressing timelines to IND filing.

The discussion revolves around leveraging stable pools for accelerated development and risk reduction through:

• In-depth characterization of lead candidates: Providing robust data for optimal drug candidate selection.
• Concurrent execution of critical development activities: Optimizing resource utilization and shortening the overall timeline.
• Toxicology batch generation from stable pools: Enabling early safety evaluations.
• Direct application of toxicology findings to cGMP final processes: Streamlining manufacturing development.

View the webinar to gain valuable insights for optimizing CLD practices and learn how to accelerate the journey toward first-in-human clinical trials and proof-of-concept studies.