Quality Control TestingIdentity

Identity tests : a result of a long-standing characterization experience

Clean Cells has long specialized in the characterization of biopharmaceutical substances and products in compliance with Good Manufacturing Practises (GMP), through substantial experience in identity testing. These are grounded in an expertise using cytogenetics and molecular (qPCR)-based techniques, thus building a comprehensive assay panel for the evaluation of biological substances from the human and animal health industries.

Our cytogenetics department is based on dedicated laboratories, a team highly trained on identity and stability matters and numerous collaborations with sponsors worldwide. Our experience covers the evaluation of cell lines to produce biopharmaceuticals and of Advanced Therapy Medicinal Products (ATMP), including cell therapy and CAR-T products (for Chimeric Antigen Receptor T cells).

Our quality control offer includes:

  • Karyotype analysis including G-banding and Fluorescence In Situ Hybridization (FISH) analysis
  • STR fingerprinting
  • RAPD-PCR based fingerprinting (replacement for isoenzyme assay)
  • Q-PCR-based species identification
  • Genetic characterization of recombinant cell lines: gene copy number, vector copy number
  • Genome sequencing
  • Bacterial identification via mass spectrometry
  • Specific qPCR-based assay development targeting genetic sequences for identification

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