Regulatory filing and approval is the first major value inflection point of drug development. With rising numbers of antibody-based therapeutics entering the development pipeline, and increased competition, there is growing pressure for biopharma developers to reduce timelines to regulatory submissions. 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.
Cell Line Development (CLD) forms the foundation of this integrated approach to biologics development. Having an approach to CLD that aims for increased speed to IND while ensuring the product is of high quality is essential. A robust CLD strategy will incorporate methods and techniques that minimize delays and risks by gathering information on cell line and molecule developability and manufacturability as early as possible.
This webinar describes how fast stable pools can quickly enable the generation of purified product from a panel of potential candidates at an early stage. We discuss how access to early material allows for key non-clinical activities to be run in parallel to significantly reduce timelines to regulatory submission.
The expert speakers discussed how stable pools can be leveraged to accelerate timelines and reduce risk by allowing:
- More in depth characterization of a panel of lead candidates to provide more robust data for lead drug candidate nomination
- Parallel delivery of critical path development activities
- Generation of toxicology batches from stable pools
- Learnings from toxicology run to be applied to cGMP final process
Register to listen to this webinar recording to learn more about an integrated approach to CLD for advancement toward first in human clinical safety and proof of concept studies.
Key Learning Objectives
- Understanding how an integrated approach to Cell Line Development and Process Development can generate overlaps and accelerate overall drug development
- How to reduce time taken to generate toxicology material
- Recommendations for how to run Process Development alongside toxicology studies
- How learnings from stable pool toxicology runs can be applied to final process