> Range of assays > Safety testing services
Stem Genomics has provided high-quality services since 2018, specializing in human pluripotent stem cells.
As part of Clean Cells, we are now expanding our detection capabilities with two new service areas available for all cell types: Microbiology Testing and Viral Screening available locally from Durham, NC and Montpellier for R&D workflows, and through Clean Cells France for GMP-certified release testing.
Sterility testing ensures that cell cultures and biologics are free from bacterial and fungal contamination, a cornerstone of good laboratory practice. Stem Genomics performs sterility tests by direct inoculation using nutrient-rich broth media supporting the growth of aerobic and anaerobic bacteria as well as fungi.
Our validated qPCR mycoplasma panel covers more than 120 strains. Unlike standard bacteria, mycoplasma are cell wall-free organisms that cannot be detected microscopically yet can significantly disrupt cellular metabolism and experimental integrity. Monitoring mycoplasma is required under global regulatory guidelines. Available for development and R&D workflows. GMP-grade testing and release documentation available via Clean Cells France on request.
Stem Genomics has designed Myco-digital, a digital PCR-based mycoplasma detection assay, to meet your needs. Highly sensitive, the dPCR technology helps reduce false positive reporting. Myco-digital allows you to meet the recommended regulatory guidance of 10 CFU/mL for 60 mycoplasma species, including the 6 species responsible for 90-95% of cell culture infections. Find out more.
Our human virus screening service is designed to protect laboratory personnel working with human-derived biological materials. Using validated qPCR assays, we test for key human pathogens including HIV-1/2, HTLV-1/2, Hepatitis B, and Hepatitis C, ensuring materials are safe to handle and free from viruses that could pose a risk to operators or compromise product quality. Flexible panels are available for R&D needs. Validated release assays are provided via Clean Cells France.
For programs requiring more comprehensive biosafety profiling: retrovirus detection, gene therapy vector safety testing (RCAAV, RCL assays), and advanced methods including transmission electron microscopy. Custom panels and development support available.
Human cell therapy products
Targeted genetic markers
Animal cells
GMP-grade release testing
hESC, iPSC, CAR-T, NK cells, MSC
Digital PCR for specific loci
Mice, pigs, cats, dogs, Chinese hamsters, rats, sheep, chickens (more on request)
Via Clean Cells France full regulatory documentation
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As of July 17, our new address will be:
400 Park Offices Drive, Room 105
Research Triangle Park, Durham, North Carolina 27713
Please note that we will be closed from July 12 to 16
during the transition.
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Join us LIVE for a Q&A session on the latest iCS-digital™ PSC upgrade.
Find out what it means for you and ask all your questions
Juline VINCENT our R&D Project Manager and Digital PCR expert will answer you LIVE.
SAVE THE DATE: Thursday, November 7, 6pm CET/9am PDT/12 pm EDT.
Join us LIVE for our webinar!
Best Practices: Making your hPSC Quality Control workflow more efficient
Join Juline VINCENT, our R&D Project Manager, as she presents efficient quality control strategies specifically designed to address the unique characteristics of pluripotent stem cells.
Thursday, October 23, 12:00 PM EST / 6:00 PM CET
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