PEGylation is the chemical linkage of polyethylene glycol polymer chains to various APIs, primarily to increase in vivo half-life and stability of the product. BioTechLogic has experience managing pre-qualification and optimization studies for PEGylation reactions. Our experience includes the development and validation of the following reaction parameters:
- Molar ratio of PEG reagent to product
- Time
- Temperature
- Mixing and static reactions
- Reagent stability
- In-process hold times