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GeneRulor Solution Portfolio

GeneRulor offers a one-stop safety assessment solution for UCAR-T development, addressing critical safety and regulatory requirements. Our solution covers the entire workflow from target design and editing validation to IND filing, with seven core modules: sgRNA target optimization & screening, gene editing tools & delivery, editing efficacy validation, off-target effect analysis, chromosomal structure assessment, vector integration detection, and editing residue detection. A multi-dimensional complementary strategy ensures scientific, comprehensive, regulatory-compliant data, while our flexible service model helps enterprises significantly shorten development cycles, reduce management costs, and accelerate product filing and clinical translation.

In vivo CAR-T therapies carry inherent risks of insertional mutagenesis and abnormal clonal expansion. To address these safety concerns, GeneRulor has developed a proprietary cfDNA liquid biopsy platform powered by LiBIS-seq technology. Achieving an ultra-high sensitivity of 0.01%, this non-invasive solution systematically profiles vector integration and tracks dynamic clonal evolution across tissues. Compatible with diverse vector types, our end-to-end analytical services deliver robust, regulatory-compliant data from preclinical development through clinical translation, providing critical safety monitoring for both in vivo and conventional ex vivo CAR-T applications.
To navigate stringent FDA and CDE regulatory mandates regarding genetic stability and off-target risks in iPSC gene editing, GeneRulor provides an end-to-end quality control (QC) solution. Our platform seamlessly integrates high-depth genomic sequencing, epigenomic multi-omics, and ultra-sensitive CRISPR off-target safety assessments. Offering both dedicated IND-enabling packages and flexible standalone services, this one-stop approach ensures dual US-China regulatory compliance while accelerating project timelines by 40–50%. Supported by expert project management, we establish a robust safety foundation across the entire therapeutic lifecycle—from early R&D and IND submission to clinical commercialization.
Generulor's one-stop in vivo gene therapy solution, centered on LvNP (Lentivirus Nanoparticles), solves the industry pain point of balancing delivery efficiency and safety. It achieves virus-level cell entry via membrane fusion and eliminates insertional mutagenesis risks through a non-integrating design. Covering 7 core safety assessment modules, our data fully complies with NMPA/FDA and GLP standards. We provide stage-tailored service packages for R&D, candidate selection and IND submission to accelerate your in vivo gene therapy clinical translation.
To overcome the protracted R&D cycles and complex data integration challenges of ASO and siRNA therapeutics, GeneRulor provides a comprehensive, IND-enabling development platform. Spanning target design, chemical synthesis, lead optimization, and comprehensive safety profiling, our integrated service is tailored to the distinct mechanisms of action of these modalities. By synergizing in silico prediction with RNA-seq transcriptomics and RT-qPCR validation, we systematically establish a robust evidence chain for hybridization-dependent off-target effects. Strictly adhering to the latest 2024 FDA guidelines and OSWG consensus, we deliver fully FDA/CDE-compliant standardized reports and safety data packages to seamlessly streamline and accelerate your regulatory submissions.
To navigate the unique challenges of both sgRNA-dependent and sgRNA-independent off-target effects inherent to base editing, alongside stringent FDA/CDE regulatory mandates for comprehensive risk evaluation, GeneRulor has developed a one-stop, dual-dimensional (DNA and RNA) safety assessment solution. Driven by core platforms in DNA off-target detection, RNA off-target detection, and site validation, we seamlessly integrate our proprietary Detect-seq and Ino-seq technologies with 100X WGS and RNA-seq to achieve comprehensive, ultra-sensitive profiling of all off-target event types. Offering both tailored IND-enabling safety packages and flexible standalone services under strict ISO9001/CNAS-certified workflows, our platform guarantees rigorous data traceability in full compliance with the latest dual US-China regulatory standards. This end-to-end service significantly shortens project timelines, establishing a definitive safety foundation from early R&D and IND submission through to commercialization, ultimately expediting the clinical translation of your base editing therapeutics.

To navigate the complex testing requirements and stringent regulatory hurdles associated with Genetically Modified Microorganisms (GMMs) in food processing, GeneRulor offers a comprehensive safety evaluation platform strictly aligned with the latest 2024 CFSA guidelines. Driven by an orthogonal "bioinformatics plus experimental validation" strategy, our end-to-end solution spans recipient strain evaluation, genetic manipulation verification, whole-genome sequencing (WGS), off-target analysis, virulence and antimicrobial resistance (AMR) gene screening, genetic stability testing, and product residue detection. Offering both tailored regulatory submission packages and flexible standalone services, this one-stop approach unifies data standards and significantly shortens project timelines. Fully compliant with domestic CFSA and international FDA/EFSA regulatory frameworks, we establish a robust safety and compliance foundation to seamlessly accelerate your GMM products from early R&D through to successful market approval.

To address the clinical challenges of variable patient responses, high relapse rates, and adverse event management in CAR-T therapy, GeneRulor offers an end-to-end R&D and companion monitoring solution strictly aligned with FDA and CSCO guidelines for 15-year long-term follow-up. Powered by a multi-tiered platform integrating bulk sequencing, single-cell sequencing, and liquid hybridization capture, our comprehensive service spans from precise pre-treatment screening to ultra-sensitive MRD tracking. By comprehensively profiling T cell clonality, tumor heterogeneity, CAR-T persistence, and immune reconstitution, we deliver critical predictive insights into therapeutic efficacy and relapse risks. Offering both complete companion monitoring packages and flexible standalone assays, this unified platform streamlines data standardization and seamlessly accelerates your CAR-T therapeutics from clinical trials through to regulatory submission and successful clinical translation.
To meet the stringent stability requirements of raw materials across the entire molecular diagnostics and next-generation sequencing (NGS) workflow—spanning sample preparation, library construction, targeted enrichment, and sequencing—GeneRulor provides a comprehensive suite of premium components. Focused on critical assay nodes, we supply high-performance library preparation kits, liquid biopsy solutions, capture reagents, magnetic bead series, and Cot-1 DNA, all engineered for seamless integration into existing customer workflows. Leveraging our scalable cell and gene therapy (CGT) manufacturing capacity and proprietary high-throughput sequencing technologies, we deliver safe, highly efficient, and strictly quality-controlled raw materials adaptable to diverse application scenarios. This robust infrastructure empowers research institutions and biopharmaceutical enterprises to achieve superior diagnostic precision and significantly accelerate assay development.
To overcome critical bottlenecks in synthetic biology—such as low modification efficiency, complex metabolic regulation, limited screening throughput, and immature phage engineering—GeneRulor provides a comprehensive, end-to-end microbial chassis engineering platform. Powered by our advanced gene-editing technologies, this solution spans de novo chassis construction, precise metabolic engineering, high-throughput screening, and rigorous genomic stability assessment. Fully compatible with diverse microbial systems including bacteria, yeast, fungi, and bacteriophages, our scalable services empower clients to seamlessly bypass technical barriers and rapidly accelerate the industrialization of biomanufacturing across the pharmaceutical and chemical sectors.
To address the end-to-end needs of CAR-T cell therapy, from construct development and manufacturing quality control to clinical follow-up and the elucidation of relapse and resistance mechanisms, GeneRulor provides a single-cell multi-omics solution for translational R&D and clinical applications. Centered on scRNA-seq and integrated with scTCR-seq, CITE-seq, bulk TCR/BCR sequencing, scATAC-seq, spatial transcriptomics, and WES, this solution is strategically configured to address the key scientific questions arising at different stages of development. It enables systematic characterization of cellular functional states, clonal evolution, epigenetic regulation, and changes in the tumor microenvironment. Through a staged and modular testing and analysis framework, the solution helps clients more efficiently accomplish construct selection, product quality standard development, dynamic efficacy monitoring, and resistance mechanism identification, thereby providing deeper, more translatable data support for CAR-T product development, IND submission, and subsequent clinical optimization.
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E-Mail：service@generulor.com
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