Potential Genotoxic Impurities
Regulatory agencies now require that drug manufacturers evaluate potential genotoxic impurities (PGI’s) present in the production of drug substances/drug product manufacturing and place very strict controls on the levels of these species. Often, PGI’s must be reduced to single-digit parts per million (PPM) levels.
At Avista Pharma, an integrated team of experienced process and analytical chemists will:
- Review your process to identify PGI’s, including the use of both structure-activity and literature-based software tools to screen structures
- Comprehensively evaluate the clinical phase of your program (including anticipated dose levels) to establish the appropriate levels of PGI control
- Utilize state-of-the-art synthetic processes to eliminate PGI’s whenever possible
- Minimize PGI levels when they cannot be eliminated
- Develop and validate the sensitive analytical methods required to quantify the levels of PGI’s present
The Avista Pharma team has sophistical analytical instrumentation – including Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography (LC)/High Resolution MS (Time-of-Flight – TOF and Orbitrap), and LC/MS/MS – and extensive experience developing trace-level analytical methods for PGI measurements.