iPSC-Derived Cell Product Solutions

Due to their unique characteristics, iPSC-derived cell products require stringent safety evaluation and quality control throughout development. Sequanta focuses on critical areas including genomic stability, on-target and off-target analysis of gene editing, and the characterization of cell differentiation and cell populations. We have developed standardized testing solutions to support product optimization, manufacturing quality control, and clinical development throughout the product lifecycle. Leveraging our integrated multi-omics platform and multidisciplinary teams with expertise in experimental science, bioinformatics, and medical genetics, Sequanta provides service solutions aligned with clinical trial quality standards and regulatory submission requirements. We have collaborated with leading industry partners to support multiple IIT and registration clinical studies, facilitate IND/NDA submissions for several drug programs, and complete thousands of clinical sample testing projects.

iPSC Solution

         Donor    →    iPSC Generation    →    Genetic Modification    →    Differentiated Cells    →     Clinical Trial

Advantages

Genomic Stability Assessment Enables Comprehensive Genetic Risk Evaluation

For iPSC-derived cell products, WES, WGS, and other sequencing approaches are used to identify various genomic variants, including SNVs, InDels, CNVs, and SVs. A multidisciplinary medical genetics team leverages authoritative variant databases and established bioinformatics pipelines to evaluate the pathogenic potential and potential tumorigenic risks of identified variants according to ACMG guidelines, and provides comprehensive testing and interpretation reports.

Provide a complete variant list and filtering logic for IND submission

Safety Assessment of Gene-Edited Cell Products

Sequanta provides comprehensive on-target and off-target risk assessment solutions for gene editing based on site-specific PCR amplification and whole-genome sequencing (WGS). These solutions are applicable to sample testing at different stages, including R&D samples, in vitro and in vivo toxicology study samples, cell banks, cell preparations, and clinical samples. For identified off-target variants, tumorigenic and pathogenic risks are evaluated and reported based on authoritative variant databases and ACMG guidelines.

Editing Efficiency Assessment

Clonality Assessment 

Residual Plasmid Assessment 

Whole-Genome and Targeted Off-Target Analysis

Population-Stratified Off-Target Analysis Integrating Human Genetic Variants

Chromosomal Integrity and Translocation Assessment

Long-Read Sequencing-Based Editing and Off-Target Assessment

Gene Editing on-Target/Off-Target Analysis

Sequanta provides comprehensive on-target and off-target risk assessment solutions for gene editing based on site-specific PCR amplification and whole-genome sequencing (WGS). These solutions are applicable to sample testing at different stages, including R&D samples, in vitro and in vivo toxicology study samples, cell banks, cell preparations, and clinical samples. For identified off-target variants, tumorigenic and pathogenic risks are evaluated and reported based on authoritative variant databases and ACMG guidelines.

Cell Population Characterization — Differentiation Profiling and Impurity Cell Identification

Single-cell sequencing is used to characterize different cell populations in cell products, analyze cellular composition, differentiation profiles, residual stem cells, and impurity cell populations, and comprehensively evaluate the quality attributes and safety of cell products.