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iPSC Cell Product Testing and Analysis Services
Cell and Gene Therapy
iPSC Cell Product Testing and Analysis Services
By their nature, iPSC-derived cell products have higher safety and quality control requirements. Focusing on key nodes such as cell genome stability, gene editing on-target and off-target assays, and cell differentiation characterization and population analysis, Sequanta Technologies has established a set of standardized service solutions to meet the needs of product development optimization, production quality control and clinical trials at all stages. Relying on professional laboratory, data analysis and medical genetics scientists with a comprehensive multi-omics platform, we provide services that meet the quality standards for drug submissions and clinical trials, and have worked with leading partners on several IIT/registered clinical trials, supported 2 BLA/NDA submissions and dozens of IND submissions, and complete thousands of clinical sample tests.
Featured Services
Cell genome stability analysis - providing professional variant pathogenicity interpretation reports

For iPSC-derived cell products, after detection of all types of SNV, InDel, CNV and SV variants by WES and WGS, the professional medical genetics scientists will assess the risk of tumorigenicity and pathogenicity of the mutations based on the authoritative mutation database and analysis process in line with the ACMG guidelines and provide a comprehensive test analysis report accordingly.

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Gene editing on-target/off-target analysis - applicable to regulatory submissions and clinical trials

We provide whole genome sequencing and PCR amplicon sequencing for detection of on-target and off-target gene editing events, suitable for samples at various stages of research and development, in vitro and in vivo efficacy and toxicology samples, cell banks, cell products and clinical samples. For off-target mutations detected, we provide a mutation interpretation report, such as tumorigenicity and pathogenicity, based on the mutation database in accordance with the ACMG guidelines.

Cell characterization and population study - differentiation analysis and impurity identification

We use single cell sequencing to study different cell populations in the cell products, analyze cell population composition,differentiation characteristics, stem cell residues, and impurity cell types, and provide a comprehensive assessment of the quality characteristics and safety of the cell products.

Solutions
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