Reviewing How to Work With CDMOs Within Korea, Asia & the Rest of the World to Ease Manufacturing & Protect Timelines
- Prioritizing CDMOs with specialized capabilities in handling complex biologics (e.g., bispecifics) and challenging conjugation processes to ensure high yield and purity specifications are met
- Establishing robust method transfer strategies for advanced analytical characterization (e.g., detecting HMW species or conjugation sites) to ensure data consistency between the sponsor and the CDMO
- Identifying critical process parameters (CPPs) early to mitigate risks associated with scaling up and ensuring a seamless transition from pilot to GMP manufacturing