Quality Control TestingIdentity
Over the years, Clean Cells has established various tools for the genetic characterization of cells and micro-organisms, notably supported by our dedicated cytogenetics laboratories. As part of this activity, we offer:
- 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
- Specific qPCR-based assay development targeting genetic sequences for identification
- Bacterial identification via mass spectrometry
These methods are applicable in the context of typical biologics generation but also for Advanced Therapeutic Medicinal Products (ATMPs) characterization.