描述
Cell and Gene Therapy
Safety Evaluation & Quality Control Solutions for CDMO/CRO 
In cell and gene therapy, CDMO/CRO has unique R & D and production quality control needs. Sequanta has developed and improved a number of characteristic testing and analysis services in a targeted manner. For example, cell bank and strain bank identification, vector sequence testing, cell genomic stability analysis, cytokine and immune marker analysis, etc., provide test reports that meet GLP quality release standards. We support "CDMO+CRO" one-stop drug research and development services to accelerate the research and development process of drug research and development companies and biotechnology companies. We provide service solutions that meet clinical trial and drug application quality standards. We have worked with leading partners in the industry to complete several IIT/registration clinical trial projects, support multiple drug IND/NDA filings, and complete thousands of clinical sample testing.
CAR-T Characterization & Testing Services
描述
描述
Sequence Integrity

* DNA/RNA Sequence Release Testing

Sanger / NGS / ONT Sequencing

Sequence Integrity Assessment

Viral Genome Sequencing-Based Release Testing

* Bacterial Genome & Plasmid Sequence * Verification for Release Testing

* Genomic Stability Assessment

* Adventitious Virus Detection Using

* Sanger Sequencing, NGS, and ONT Sequencing

Safety Assessment / Safety Evaluation

* Genomic Integration Sites

* Gene Editing Efficiency

* Gene Editing Off-Target Analysis

Targeting Distribution

* Drug Biodistribution

* Target Organ Specificity

Immune Response

* Inflammatory Immune Response

Long-term Follow-up Monitoring
In Vivo Biodistribution Monitoring
Inflammatory Adverse Event Monitoring
Advantages
Full-Length Vector Sequence Analysis and GLP-Compliant Quality Release Testing
Diversified Solutions: We leverage multiple sequencing technology platforms, including Sanger sequencing, next-generation sequencing (NGS), and third-generation sequencing. With extensive experience across various sample types, we provide comprehensive analytical reports covering sequence integrity assessment, mutation analysis, and other relevant analyses. Customized GLP-compliant testing services are available according to customer requirements, supporting IND submissions and quality audits by customers and regulatory authorities.
VectorTypesLengthDetection method
PlasmiddsDNA-Sanger、NGS
LentivirusssRNA6-6.5 kbSanger, NGS, third-generation sequencing
RetrovirusssRNA7-12 kbSanger, NGS, third-generation sequencing
Adeno-associated virusssDNA5 kbSanger, NGS, third-generation sequencing
AdenovirusdsDNA35-40 kbNGS, third-generation sequencing
Vaccinia virusdsDNA190 kbNGS, third-generation sequencing
Herpes simplex virus (HSV)dsDNA140 kbNGS, third-generation sequencing
mRNAssRNA3-5 kbSanger, NGS, third-generation sequencing


Adventitious Agent Testing — Multi-Species Contamination Detection in Cell Products
This service leverages high-throughput whole-genome sequencing technology to detect exogenous viral contamination in cells. By comparing sequencing data against up-to-date databases, it comprehensively identifies potential contamination risks associated with human, murine, bovine, porcine, and other species. The service is applicable to a wide range of sample types, including cell banks, strain banks, virus banks, cell products, viral products, donor samples, and other biological materials.
Based on next-generation sequencing (NGS)
Species-Level Detection
Broad Detection Spectrum, Covering Various Viruses and Mycoplasma
Applicable to Cell Banks and Cell Products (Culture Supernatants Recommended)
Applicable Product Types: Viral Products
Based on next-generation sequencing (NGS)
Species-Level Detection Resolution
Higher Sensitivity Than Metagenomic Sequencing
Covering Key Viruses
Applicable to Cell Banks and Cell Products (Culture Supernatants Recommended)
Applicable Product Types: Viral Products