Establishing Process & Analytical Readiness for First Oligonucleotide Programs to Enable IND Filing & Seamless Technology Transfer
- Defining the critical analytical, process, and raw material requirements across DS and DP to support IND submission
- Designing scaled-down models and analytical strategies to build process understanding and de-risk scale-up
- Overcoming technical and organizational challenges in early CDMO partnerships and technology transfer to ensure alignment on methods, specifications, and accelerate GMP readiness