Cytogenetic Assays for Genotoxicity QC
Genotox assays for genetic stability, and QC. From one sample submission analyze your therapy with orthogonal localized and whole genome assays.
Ensuring the genomic integrity of your therapeutic pipeline is an absolute imperative in today’s regulated landscape.
At KromaTiD, we offer a comprehensive suite of cytogenetic assays designed to provide you with a robust foundation for genotoxicity assessment. By packaging our cytogenetic assays, including dGH in-Site™, dGH SCREEN™, Genotox G-Band Karyotyping, and Digital PCR, you can achieve a level of insight that is unparalleled. This comprehensive approach is your key to secure and efficient drug product development and successful Investigational New Drug (IND) filings.
The Power of Our Assay Package
dGH in-Site™:
- Our dGH in-Site™ assay excels in identifying genome-wide structural variations, on- and off-target gene-editing analysis with precision. It allows you to delve deep into the structural aspects of your genetic material and uncover even the subtlest anomalies.
dGH SCREEN™:
- The dGH SCREEN™ assay is your shield against genomic instability. With this assay, you can efficiently identify and evaluate a broad range of genetic alterations, ensuring that your therapeutic pipeline remains stable and secure.
Genotox G-Band Karyotyping QC:
- Our Genotox G-Band Karyotyping assay provides the classical yet invaluable insight into the structural characteristics of your chromosomes. Starting at 100 cells per sample, our expert cytogeneticists will customize reporting based on the genotoxicity assessment of your wild type and edited cells side-by-side in comparison reports.
Digital PCR-Powered Genotoxicity Assays: Elevating Quality Control:
In the realm of quality control, precision is paramount. Our Genotoxicity Assays, empowered by Digital PCR technology, provide the accuracy and reliability needed to maintain the highest standards of product quality. Explore how we harness the power of Digital PCR to ensure the genomic integrity of your product.
A Comprehensive Approach
By complementing the above assays with your existing repertoire, including Next-Generation Sequencing (NGS), you create a formidable combination. KromaTiD’s assays, combined with your existing toolbox, provide you with the most comprehensive genotoxicity dataset available.
The KromaTiD Advantage
Comprehensive Genome-Wide Structural Variation Analysis:
- Only with KromaTiD can you comprehensively measure genome-wide structural variations. This level of insight ensures that no aspect of genetic integrity goes unnoticed.
Genomic Integrity Assurance:
- With KromaTiD’s comprehensive assessments, you can confidently navigate the therapeutic development process, knowing that your therapies are grounded in genetic integrity.
Your therapeutic pipeline deserves nothing less than a gold standard in genotoxicity assessment. By packaging KromaTiD’s cytogenetic assays with your existing methods, you can fortify your approach, ensuring that you have the most extensive genotoxicity dataset to support your endeavors. The result? Confidence in the safety, quality, and integrity of your therapeutic pipeline, achieved through a collaboration that is truly comprehensive, powerful, and unique to KromaTiD.
Develop Study Plans to Qualify Cytogenetic Release Assays with G-Band Karyotyping for QC
KromaTiD provides quality control karyotyping for your cell lines. Starting at 100 cells per sample, we will provide Genotoxicity G-Band Karyotyping analysis on your cells. Two genomic integrity reports on your wild type and treated cells are provided along with a side-by-side comparison of genomic stability. Design a study plan with KromaTiD to qualify G-Banding as a release test to monitor batch-batch consistency.
Our qualification study plans includes sections to address the individual phases and provide the following:
- Pass/Fail assessment
- Serial dilution for limit of detection
- Intermediate precision
- Custom reporting
Contact Us Today!
Contact us to set-up a discussion on how we can assist you with your cytogenetic assays for genotoxicity for QC for your therapeutic pipeline.