Qualification & validation of analytical methods

Some analytical methods may be qualified and validated (linearity, accuracy, specificity, repeatability, limit of detection and sensitivity) at PX'Therapeutics according to project progress and/or customer constraints. Method validations are performed according to ICH guidelines.

 

Some examples:

 

  • Western blotting for identity determination
  • RP-HPLC for purity assessment
  • UV dosage for protein quantification
  • Endotoxin dosage by LAL test
  • Residual DNA by qPCR
  • Cell proliferation for potency assay, etc.