Benefits of Early Impurity Analysis to Pharmaceutical R&D

We presented two/ posters at the CoSMoS 2013 (Conference on Small Molecule Spectroscopy) in San Diego this month.  This poster titled Why Bother with the Little Peaks? Benefits of Early Impurity Analysis to Pharmaceutical R&D is a case study exploring the effectiveness of SFC in isolating impurities from complex mixtures or bulk compound samples.

It’s become customary to identify minor impurities late in the process of drug development.  Partly this is because the FDA doesn’t require a complete suite of information until the drug is close to the approval stage, but partly it’s because this work is time-consuming and demanding of analytical resources.

Suppose impurity isolation and characterization could be efficiently and inexpensively accomplished early in compound development. Opportunities could arise to:

  • Improve scale-up chemistry
  • Develop a better GMP process
  • Improve the quality of clinical trials material
  • Enhance definition and granularity in CMC filings
  • Further de-risk late stage studies

*The other poster presented at CoSMoS in 2013 – Targeted Isolation of Impurities in Pharmaceutical Compounds using SFC