Impurity testing

Impurity testing in bioproduction involves identifying and quantifying unwanted substances that may be present in biological products, such as vaccines, monoclonal antibodies, and recombinant proteins. These impurities can originate from various sources, including raw materials, cell culture processes, and downstream processing steps. Ensuring the purity and safety of biologics is critical, as impurities can affect the efficacy, stability, and safety of the final product.

Regulatory bodies such as the Food and Drug Administration (FDA) in the USA and the European Medicine Agency (EMA), issue specific guidelines regarding impurity testing. To ensure the safety of patients, they require high levels of qualification and validation to meet assay criteria.

As GMP-licensed company, Clean Cells offers many Process-related impurity assays meant to detect and quantify:

  • Proteins from the host cells used to produce the biologic product: Residual Host Cell Protein (HCP) quantification by ELISA method. 
  • Genetic material from various cell origins (human, eukaryotic, prokaryotic): Residual Host Cell DNA quantification by Polymerase Chain Reaction (PCR). 
  • Quantification of plasmid gene sequences used in gene therapy processes via qPCR (kanamycin, VSV-G, HIV-GAG, AE1, SV40, HIV-PSI).
  • Toxins derived from bacterial cell walls that can cause adverse reactions in patients : Endotoxin testing using chromogenic Limulus Amebocyte Lysate (LAL) assay).
  • Residual reagents quantification (BSA, benzonase) 
Impurity testing

Reach out to us for more information on our testing capacity or impurity assay development.

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