How can mAb programs reach the clinic in as little as six months without increasing CMC risk? Are regulators comfortable with pool-derived material?
In this extended Q&A, Dr. Megan Mason, Global CMC Process Development Implementation Lead, and Dr. James Berrie, Global CMC Strategy and Process Development Technical Director, address common questions about accelerated DNA-to-IND programs—from regulatory acceptance and cell line stability to analytical strategy, downstream processing, toxicology data and drug product readiness.
Key takeaways:
- Scientific innovations behind the 6-month DNA-to-IND approach
- Regulatory considerations for pool-derived material
- Platform strategies that accelerate development timelines beyond mAbs
- How quality and CMC risk are managed during acceleration
