CGT Analytical Services

Including autologous/allogeneic CAR-T cells targeting CD19, BCMA, etc., covering key quality control indicators such as gene editing efficiency, residual impurities, and cell stability during cell preparation;

CAR-NK products adapted for natural killer (NK) cell modification , with testing conducted on core dimensions such as cell activity, gene accuracy, and off-target effects;

Covering iPSC reprogramming efficiency verification, genetic stability testing, differentiation potential assessment, and quality control testing of various functional cells (such as cardiomyocytes and nerve cells) differentiated from iPSCs;

Include TCR-T cells, mesenchymal stem cells (MSCs), and dendritic cells (DCs), catering to the personalized quality control needs of different cell types.

• The testing laboratory strictly adheres to the GMP quality management system, and the testing process is traceable and verifiable.

• The test report meets the application standards of major global regulatory agencies such as NMPA, FDA, and EMA.

• It can efficiently detect low- abundance gene mutations, exogenous pollutants, and cellular impurities;

• For gene editing products, it can accurately detect editing efficiency and off-target sites, ensuring the accuracy and safety of gene editing.

• High-throughput parallel detection: Simultaneously completes multiple indicators such as gene sequence verification, copy number analysis, gene expression profiling, and microbial contamination screening, significantly improving quality control efficiency;

• Customized analysis process: Optimize library construction and data analysis schemes for different cell therapy products' technical routes (such as viral vector transduction, electroporation transfection, and gene editing) to ensure the relevance and reliability of test results.

• Gene editing efficiency testing: Validating the insertion efficiency and integration site analysis of target genes such as CAR genes and TCR genes;

• Off-target effect detection: Through whole-genome sequencing (WGS) or targeted sequencing, accurately identify off-target sites of gene editing tools such as CRISPR and TALEN, and assess potential risks;

• Genetic stability assay: Monitor copy number variation (CNV), structural variation (SV), and gene mutations in cells during in vitro expansion, cryopreservation and thawing, and induced differentiation.

• Screening for exogenous contaminants: Detecting microbial contamination such as bacteria, fungi, mycoplasma, endogenous retroviruses (ERV), and viral vector residues;

• Batch consistency analysis: Compare the genetic characteristics and quality control indicators of products from different production batches to ensure the stability of mass production.

• Cell identification: The authenticity and uniqueness of the cell origin are confirmed through STR typing and specific genetic marker detection.