Quality Control TestingPurity

Purity : a critical testing stage

Purity testing is an essential step of a comprehensive characterization strategy to ensure safety and efficacy of biological products. For several years, Clean Cells has developed and validated a full portfolio of assays typically used for the control of all categories of biopharmaceuticals, including purity controls such as:

  • Residual Host Cell Protein (HCP) quantification
  • Residual DNA testing (human, eukaryotic, prokaryotic)
  • Quantification of plasmid gene sequences used in gene therapy processes via qPCR (kanamycin, VSV-G, HIV-GAG, AE1, SV40, HIV-PSI).
  • Endotoxin testing (chromogenic LAL assay)
  • Residual reagents quantification (BSA, benzonase)

Please reach out to the team for additional information or to discuss bespoke assay development.