Brooke Koshel
Director - Process Development Wave Life Sciences Ltd.
Seminars
Wednesday 19th August 2026
Bridging Process Development & CMC to De-Risk Scale-Up of Oligonucleotide Therapeutics Toward Commercial Readiness
9:00 am
- Designing process development strategies that proactively define critical process parameters (CPPs) and critical quality attributes (CQAs) to enable a seamless transition into robust CMC control strategies
- Translating early-phase process understanding into scalable, reproducible manufacturing workflows to minimize variability and avoid late-stage rework during scale-up
- Establishing effective knowledge transfer between process development, analytical, and CMC teams to ensure alignment on impurity control, process consistency, and regulatory expectations
