Nucleic acid detection is commonly used in the quality control inspection of biological products. Compared to traditional methods and qPCR, NGS can detect unknown novel viruses with unbiased detection, a wide detection range, high accuracy and sensitivity, and high safety. NGS platform can be used for cell line characterization, adventitious agent testing and whole-genome sequencing.
SHENTEK NGS platform provides professional GMP-grade detection services, including nucleic acid extraction, library construction, sequencing, bioinformatics analysis, and report interpretation, to meet the safety requirements for biological quality control.
Complete Bioinformatics Analysis:
Self-developed process and quality control, SHENTEK effectively limit background noise and interference, ensuring stable and reliable detection results.
Specialized NGS Database:
SHENTEK has autonomously constructed NGS database encompassing viruses, genomes, and vectors essential for the biological testing.
Complete Data Management:
SHENTEK comprehensively record the library construction process and related data, create a code management system to record the evolution of the bioinformatics analysis process, and meet the FDA 21 CFR Part 11 regulations.
Based on professional biosafety testing knowledge and advanced NGS technology platform, SHENTEK provides customers with the following services:
Adventitious Virus Testing
SHENTEK NGS can effectively remove host genes from different samples and enhance detection sensitivity. SHENTEK has developed cell libraries, strain libraries and virus libraries to detect exogenous viruses.
Virus Seeds Sequence Detection
In gene therapy, viral vectors are usually deleted genes associated with pathogenicity, virulence, or replication ability to ensure biosafety. SHENTEK NGS can perform NGS whole-genome sequencing on viral seed samples, compare and analyze the sequencing results with the expected sequences, detecting and confirming the viral sequences.
Cell Line Characterization
SHENTEK NGS can obtain the following information from cell bank in a single process:
a. Species identification;
b. Source identification of the genus;
c. Large structural changes in chromosomes;
d. Genetic drift;
e. Contamination by exogenous factors;
f. Inter-species contamination;
g. Intra-species contamination;
Gene Stability Test
Whole transcriptome sequencing: Confirm the integrity of the product transcripts.
Whole genome sequencing: Genomic structure of integration sites.
Whole genome sequencing: Ratio of inserts relative to gene copy number in the host genome.
Adventitious Agent Identification
SHENTEK NGS platform utilizes metagenomic sequencing to detect and identify adventitious agent, such as bacterial, fungal, mycoplasma, mycobacterial, and spirochete contamination.
Customized NGS Detection
SHENTEK bioinformatics platform can provide customers with quality control analysis of biological products based on NGS data, such as exogenous virus detection, virus genome assembly and mutation detection, genetic stability analysis, etc.
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