Ensuring the purity, safety
& compliance of your biologics

Impurity testing is a critical quality control step in bioproduction, protecting patient safety and product integrity. Even traces of contaminants can alter the efficacy or trigger an unwanted immune response jeopardizing the product release.  

Impurities originate from host cells, raw materials, or downstream processes. They must be carefully identified and quantified to meet regulatory standards to prevent costly deviations, investigations, and requalification later in development.

At Clean Cells, we provide GMP-certified impurity testing services to support the development and manufacturing of vaccines, monoclonal antibodies (mAbs), recombinant proteins, and gene therapies. 
Regulatory agency such as FDA, EMA, and international pharmacopeias (USP, EP) impose strict impurity testing requirements. Our validated assays help you achieve full compliance and secure patient safety.  

Impurity Testing Services

  • Residual Host Cell Protein (HCP) testing
    • Quantification by ELISA method to monitor purification efficiency
  • Residual Host Cell DNA testing
    • Residual DNA quantification by qPCR validated according to ICH Q2 guidelines
      • Coverage: Human, CHO, Vero, Mouse, Canine, Duck, Insect, Avian, Bacterial…
      • Compliance: EP§2.6.35, USP <509>, FDA (<10 ng/dose)
    • DNA Fragment sizing by Digital PCR
      • Specification: <200 base pairs, as required by FDA.
        Relevant for Human, CHO and vero-based products

Together, these assays provide a robust approach to monitoring and controlling residual DNA risks in biologics.

  • Residual Plasmid DNA and Gene Sequence Testing
    • Targeted qPCR (kanamycin, VSV-G, HIV-GAG, AE1, SV40, HIV-PSI) for plasmid or vector-derived sequences
  • Endotoxin Testing
    • Chromogenic Limulus Amebocyte Lysate (LAL) assay, ensuring the absence of specific pyrogenic contaminants that could compromise product safety at release
  • Residual reagents quantification
    • Measurement of residual BSA, benzonase and other process reagents to verify downstream clearance and compliance
Impurity testing

Clean Cells: Your Reliable Partner in Impurity Testing

  • Comprehensive portfolio of impurity assays for proteins, DNA, endotoxins, and reagents
  • GMP-certified laboratory operating under strict QA processes
  • Advanced technologies (qPCR, digital PCR, ELISA, LAL assays)
  • Expertise across biologics: with a strong track record from vaccines, mAbs, recombinant proteins, viral vectors, gene therapies to new modalities
  • Customized solutions adapted to your needs in terms of molecule, matrix, and stage of development

Contact our experts today to discuss and define the optimal impurity testing strategy for your program. 

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