描述
Cell and Gene Therapy
Cell and Gene Therapy
Testing and Analysis services for ll stages of CGT developing
As “living” drugs, cell and gene therapies face more challenges in quality control and safety during drug development, production, clinical trials and commercialization. With a sound multi-omics platform, professional laboratory, data analysis and medical genetics scientists, Sequanta Technologies can provide services for discovery and preclinical bioanalytical studies, safety and CMC testing, and clinical trial sample testing.

We support cell therapies such as CAR-T, CAR-NK, iPSC and HSC, as well as gene therapies such as gene editing, AAV and mRNA. Our featured solutions include integrated vector insertion site and copy number analysis, gene editing on-target and off-target analysis, cell genome stability analysis, cell marker and differentiation characterization, cytokine and immune marker analysis, and vector sequencing We provide high quality services 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. 
Service Scope
Cell Therapies

•Immune cells: CAR-T , CAR-NK, TCR-T, TIL

•Stem cells: iPSC, HSC, MSC

Gene Therapies

•AAV, Gene editing, mRNA

•ASOs, Oncolytic viruses

CRO/CDMO cooperation

•Plasmids, Viruses, Bacteria, Cells, Animal Models, Clinical Trials

Featured Services
For immune cell therapies-CAR-T, CAR-NK, TCR-T, TIL ......
CAR vector copy number detection

qPCR, single cell copy number analysis

Integrated vector genome insertion site analysis

for lentiviral vectors, transposon systems, etc.

Immune marker analysis

multiplex cytokine detection, immune signaling pathway analysis

TCR sequencing

cell lineage tracking

For iPSC-derived cell therapies - iNK, Neuron ......
Cell genome stability analysis

provide variant interpretation based on ACMG guidelines

Gene editing on-target and off-target detection

PCR, WGS, single cell on-target and off-target analysis

For safety and CMC testing
Vector QC sequencing

plasmid, LV, AAV, mRNA, etc.

Cell and microbe identification

STR, engineering microbial strain identification

Adventitious agent virus detection

human-derived, murine-derived, porcine-derived and bovine-derived viruses

Support IND submission and clinical trial testing
GLP testing services
Center laboratory and testing services for clinical trials
Support submissions in China and the USA
Solutions
描述