Epigenomics Analysis

Epigenomics Analysis

Gene editing, vector transduction, and ex vivo expansion may induce unintended epigenetic alterations — including changes in DNA methylation patterns, aberrant chromatin accessibility, and histone modification reprogramming — that can affect cellular differentiation potential, immunogenicity, and functional stability, posing latent safety risks. GeneRulor has established a multi-dimensional epigenomics detection platform for comprehensive characterization of the epigenome in cell therapy products. ATAC-seq (Assay for Transposase-Accessible Chromatin with Sequencing) captures open chromatin regions to reveal transcription factor binding sites, enhancer activity changes, and chromatin remodeling events, assessing the impact of gene editing on gene regulatory networks. CUT&Tag technology, with its low cell input and high signal-to-noise ratio, enables precise mapping of histone modifications (e.g., H3K27ac, H3K4me3, H3K27me3) and transcription factor binding, suitable for epigenetic profiling of rare cell subpopulations. For DNA methylation analysis, we offer multiple technical approaches — including RRBS (Reduced Representation Bisulfite Sequencing), methylation amplicon sequencing, and methylation-targeted capture sequencing — covering genome-wide, gene-set-specific, or CpG island methylation analysis. For products modified by epigenetic editors (e.g., dCas9-DNMT/TET fusion proteins), we provide WGBS (Whole Genome Bisulfite Sequencing) for single-base resolution assessment of methylation editing efficiency and off-target evaluation. iPSCs and iPSC-derived cells, as key regulatory subjects, are supported by iPSC editing WGBS to ensure epigenetic memory erasure and differentiation stability during reprogramming. All results are integrated with bioinformatics analysis, correlating gene expression profile changes and providing joint epigenome-transcriptome interpretation to support CMC and safety evaluation of the product.