Mastermind Session: Advancing Release Testing & CMC Methodologies for Radioconjugates Integrating HPLC, Gamma Spectrometry, & Isotope Supply Constraints
- Developing rapid radioHPLC and gamma-spectrometry protocols to monitor- radiochemical purity and metal impurities
- Adapting release workflows to address hot verus cold material differences and short isotope h-alf-lives
- Defining critical quality attributes and phase III CMC expectations based on binder and isotope-specific characteristics