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.