Genotoxicity Analysis Services for Cell Therapy Manufacturing

Precision Genomic Insight through dGH™ and dPCR Assays for Structural Variants and Genome Stability 

Noble Life Sciences and KromaTiD created the ultimate assay for genome stability, DNA repair, and mutagenic activity. 

Access cutting-edge genotoxicity assays, with Noble Life Sciences and KromaTiD combined suite of services designed to enhance your research and drug discovery and development pipeline. Our collaboration integrates Noble’s dPCR expertise with KromaTiD’s advanced dGH assays, providing comprehensive genotoxicity analysis.

This includes examining genome stability, DNA integrity and transgene copy number variation. Our partnership combines precise genetic analysis (digital PCR) with single-cell analysis (dGH assays) for comprehensive genotoxicity assessments. Together Noble and KromaTiD will help you ensure the quality and safety of your cell and gene therapy products facilitating regulatory compliance and expediting drug development.

Noble’s Digital PCR Expertise

Our expertise in digital PCR (dPCR) unlocks a world of possibilities for genotoxicity analysis, enabling you to gain profound insights into your therapeutic interventions.

Transgene Copy Number Analysis: Noble’s dPCR services are your premier choice for accurately detecting and quantifying copy number variations in both endogenous genes and transgenes. Whether you’re introducing genetic modifications through CRISPR/CAS, conducting a CRISPR screen, TALE, or other methods, our dPCR applications for cell and gene therapy products deliver precision and accuracy for quality manufacturing.

Our assays cover vector copy number, transgene copy number, percentage of modified cells, and contaminant testing. Noble’s reproducible dPCR process offers an efficient way to measure modification percentages and quantify vector numbers with minimal sample requirements, making it applicable at multiple stages of the cell therapy manufacturing process.

Discover the science behind our dPCR competencies.

Noble Life Sciences

Digital PCR QIAGEN QIAcuity Machine

Our state-of-the-art dPCR platform includes the QIAcuity instrument from QIAGEN. This advanced machine offers precise and reliable digital PCR capabilities, featuring high sample throughput and exceptional data quality. With the QIAcuity QIAGEN system, we ensure accurate and reproducible results for your digital PCR studies.

KromaTiD’s Unique Offering

Explore the impressive solutions offered by KromaTiD, our valued partner for genetic research and analysis.

dGH™ Assays for Genotoxicity

KromaTiD’s dGH assays offer unparalleled single-cell analysis capabilities, enabling the reliable detection of structural variations within heterogeneous cell populations and are ideal for tracking cellular engineering outcomes. These assays are also invaluable for biomarker discovery and uncovering disease-driving genetic variants.

  • dGH in-Site for Gene Editing: Whether you’re working with CRISPR/CAS, TALE, or zinc-finger editing techniques, KromaTiD’s dGH in-Site™ is your trusted ally. It provides structural analysis of baseline and edited cell populations, allowing you to optimize your editing processes. Quantify and identify on- and off-target effects for quality control in your editing trials, regardless of the gene editing method employed.
  • dGH SCREEN: KromaTiD’s dGH SCREEN goes beyond conventional cytogenomic methods, producing the rearrangement data needed to create genome stability and structural variance profiles for complex, heterogeneous cell populations. It provides a powerful whole genome assessment enabling you to track the persistence of variants over time, passages and process variable changes.

KromaTiD’s Genotoxicity G-Banding offers a structured approach to the design of cytogenetic release assays for regulatory compliance, ensuring consistent monitoring of batch-to-batch variations.


  • Genotoxicity G-Banding Services: Starting with as few as 100 cells per sample, KromaTiD’s genotoxicity karyotyping provides you with a comprehensive understanding of genomic integrity. KromaTiD provides you with a customized Genomic Integrity Report, tailored to your needs and project. This detailed view of genomic stability is essential for maintaining batch-to-batch consistency.

Unlock the Synergy of Noble and KromaTiD

Together, we accelerate your drug development pipeline, supporting regulatory compliance and the highest standards of genomic integrity. Contact us today to embark on your genotoxicity assessments and discover the limitless potential of our joint services.

Noble and KromaTiD Services

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Frequently Asked Questions (FAQs)

What is Genotoxicity?

Genotoxicity refers to the property of certain manipulations or agents, such as chemicals or radiation, to damage the genetic information within a cell. Genotoxic exposures have the potential to cause mutations or other genetic alterations, which can lead to various adverse effects, including cancer. Genotoxicity testing is conducted to assess the ability of processes or substances to cause such genetic damage.

What is Genotoxic?

Genotoxic is an adjective used to describe processes or agents that have the capability to cause genetic damage. Genotoxic agents can induce mutations or genetic alterations in an organism’s DNA, potentially leading to harmful effects such as cancer or immune diseases.

What is Digital PCR (dPCR)?

Digital PCR (dPCR) is a highly sensitive molecular biology technique used to quantify the amount of a specific DNA or RNA target in a sample. It involves the partitioning of a sample into thousands of individual reaction chambers, where each chamber can be analyzed separately. This method provides precise and absolute quantification of DNA or RNA molecules, making it valuable in applications like copy number variation analysis, rare mutation detection, and quantifying gene expression.

What is digital PCR used for?

Digital PCR has diverse applications in various fields, including:

  • Quantification of gene expression levels.
  • Detection and quantification of rare genetic mutations.
  • Copy number variation analysis.
  • Pathogen detection in clinical diagnostics.
  • Environmental testing, such as monitoring water quality or assessing biodiversity.
  • Residual DNA QC test of manufactured products.
  • In vivo biodistribution analysis of cell and gene therapeutics in safety studies.

How does digital PCR work?

Digital PCR works by partitioning a sample into many individual reactions, each containing a single target DNA molecule. These reactions are then subjected to PCR amplification, where the target DNA is amplified to detectable levels. After amplification, each individual reaction is analyzed to determine if it contains the target DNA (positive) or does not (negative). By counting the positive and negative reactions, digital PCR provides an absolute quantification of the target DNA with high precision and sensitivity.

What is Vector Copy Number?

Vector copy number refers to the number of copies of a specific genetic plasmid or virus genome (often used in gene therapy or genetic engineering) present in a cell or sample. It is crucial to determine vector copy number accurately when working with genetically modified cells or organisms to ensure the desired genetic modifications are achieved, maintained and reproducible.