Averica Discovery’s Targeted Isolation™ process rapidly develops a unique isolation strategy for each impurity. A frequent goal is to isolate a quantity of each impurity for impurity profiling and structure elucidation. The critical information gained speeds candidate development from IND-enabling studies to NDA.
Averica’s impurity isolation and characterization begins with an exchange of data, knowledge, and methods so that a project can move quickly to isolation work. Averica’s scientists develop methods to enrich and finally purify each peak of interest, rotating between preparative chromatography and analysis and isolation in a pattern uniquely designed for each target peak. Isolation of milligrams of pure compound – even when dealing with a 0.01% impurity – is often possible.
Averica’s Targeted Isolation™ has been a remarkably successful program supporting both drug substance and drug product development. Whether solving problems during clinical development, completing CMC filings, or improving GMP synthesis, Averica’s impurity isolation is a proven strategy for reducing development cost and time.
- Isolate needed trace impurities from mixtures for structure work or assay
- Determine structures of unknown substances
- Isolate impurities from drug substance or drug product
- Scale up to isolate reference standard supply
- Access difficult to isolate impurities