cGMP SHORT TANDEM REPEATS (STR)

Did you know that between 18-36% of the cell lines used in research and industry labs worldwide are misidentified, contaminated or have genetically drifted¹? Cell line authentication (CLA) is an essential quality control measure to verify a line's identity to ensure the integrity and reproducibility of your experiments. 

Many journals and funding agencies like the NIH now require researchers to provide cell line identity verification prior to submission. Additionally, the FDA requires authentication of materials used in investigational new drug (IND) applications. Short Tandem Repeats (STR) genotyping is currently the industry gold standard methodology for CLA². 

WiCell’s cGMP STR Profiling Service addresses this important need to confirm, authenticate, and verify the identity of human cell lines in translational research and clinical applications. Executed by our team of highly-trained professionals in compliance with cGMP guidelines and best practices, we can authenticate the identity and purity of the human cells and cell lines critical to your research, as well as your cell based products intended for clinical use.

STR genotyping relies on the analysis of Short Tandem Repeats (STRs), which are 2 to 6 base pair polymorphic DNA sequences scattered throughout the genome. The STRs are amplified using PCR and separated using capillary electrophoresis. The specific pattern, location, and number of these short repeats is highly variable between individuals, creating a unique STR fingerprint for each cell line. The resulting profile is then compared with a reference sample to verify cell line identity. 

We recommended authenticating your cell lines to:
• Monitor identity of a cell line during prolonged culture
• Rule out culture cross-contamination of banked cells or cell therapy products
• Establish an STR profile of a newly derived or reprogrammed cell line
• Confirm relationship of iPS cells to their parent line

We perform STR profiling on live culture or frozen cell pellet samples using the Promega PowerPlex 16HS system to analyze STR profiles and detect:
• STR polymorphisms across 15 loci plus amelogenin
• Cell-line cross contamination at levels as low as 2-5% 

Our cGMP testing services are extensively documented and undergo rigorous quality review to ensure full traceability and regulatory compliance throughout the testing process. We authenticate cell lines by comparing the STR profile of the sample to any other cell lines previously tested by WiCell. 

Additional cGMP testing services at WiCell include cGMP karyotype and cGMP FISH, providing researchers with a comprehensive, regulatory compliant characterization toolkit to validate the authenticity, genomic integrity, and suitability of cell lines for translational research, development, and clinical applications.

The results for your cell line will be provided in a comprehensive cGMP STR Analysis Report and a Certificate of Compliance, which certifies that the STR testing was completed with cGMP compliance and meets requirements for FDA submissions. 
• View an example cGMP STR Analysis Report.
• Additional information is provided on our Glossary of STR Report Terms.