Induced Pluripotent Stem Cells (iPSCs) combined with CRISPR gene editing enable universal, off-the-shelf cell therapy products. However, genomic instability, off-target effects, and epigenetic abnormalities during reprogramming and culture remain critical bottlenecks to clinical translation.
iPSC technology is transforming cell therapy from personalized to universal. Global regulators have imposed unprecedentedly strict safety requirements for iPSC-derived products.
In "Safety Testing of Human Allogeneic Cells", the FDA explicitly requires whole genome sequencing (WGS) and analysis for extensively expanded cells including iPSCs. For gene-edited stem cell banks, WGS must be performed at a minimum depth of 50X, with comparison against the COSMIC oncogenic mutation database to screen for SNVs, InDels, CNVs, and SVs.
Core Requirements: 50X WGS Depth | COSMIC Database Comparison | Gene-Edited Cell Banks as MCB | Comprehensive Variant Screening
Our solution is supported by three core technology platforms, covering the entire workflow from iPSC banking to IND filing, providing one-stop safety assessment services.
Uses ≥50X depth whole genome sequencing (WGS) and whole exome sequencing (WES) combined with multi-algorithm variant detection strategies to comprehensively screen SNVs, InDels, CNVs, and SVs. All variants are compared against the COSMIC database with a focus on oncogenic mutations.
Detection Sensitivity: 0.1% VAFIntegrates three complementary technologies: WGBS (Whole Genome Bisulfite Sequencing), CUT&Tag (Histone Modification Profiling), and ATAC-seq (Chromatin Accessibility Analysis) to comprehensively evaluate iPSC epigenetic stability across three dimensions.
Employs a three-tier "Predict – Validate – Annotate" strategy combining GUIDE-seq, AID-seq, and PEM-seq gold-standard detection methods to comprehensively identify and validate potential off-target sites with ultra-high sensitivity down to 0.01%.
Detection Sensitivity: 0.01%We possess the most complete iPSC safety assessment technology chain in China, with deep regulatory expertise and full-process support from design to filing.
One of the few domestic companies simultaneously capable of providing end-to-end services across genetic stability testing, epigenomic multi-omics, off-target detection, on-target validation, vector integration analysis, and tumorigenicity risk assessment. Standardized ISO 9001/CNAS processes ensure accurate and reliable results.
Successfully served multiple leading CGT companies with in-depth understanding of IND filing regulatory requirements and technical challenges for iPSC gene-edited products. We provide not only testing data but also complete regulatory submission packages compliant with global standards.
Supports both all-inclusive packages and individual services, with customized solutions tailored to each client's specific needs and budget. From standardized IND filing packages to full-process custom services, we offer multiple options to meet diverse requirements.
Each project is assigned a dedicated one-on-one project manager for full tracking and rapid response. Our unified technology platform ensures data consistency and traceability, reducing traditional project timelines from 6-9 months to just 3-5 months.
We offer two service models to meet the needs of different clients at various development stages.
Clients preparing for IND filing requiring complete safety assessment data
Deliverables: Complete IND-compliant testing report + expert interpretation + regulatory support
Clients with specific testing needs requiring flexible combinations
Deliverables: Single or multiple testing data reports + technical support
Our one-stop solution significantly reduces your project cost and timeline while improving regulatory submission success rates.
Tell us about your product type and development stage. We will provide a customized iPSC safety assessment plan and timeline compliant with FDA/CDE requirements.
![Micromessenger Scan to consult](javascript:Site.hoverQrCode("//33974620.s21i.faiusr.com/2/ABUIABACGAAg9by4zQYo7oak_wUwxwY40QY.jpg",this,{"tips":"请使用微信扫一扫"});){kind=link}
![Linkedin LIN HUABING](javascript:Site.hoverQrCode("//33974620.s21i.faiusr.com/4/ABUIABAEGAAgloWpzgYo0eeGgAUwhgQ4igQ.png",this,{"tips":"Scan QR code"});){kind=link}