Safety assurance in viral vector research and production
Viral vector detection is a core detection solution specifically designed for biomedical fields such as gene therapy and cell therapy. Relying on the high sensitivity and high accuracy advantages of next-generation sequencing (NGS) technology, it provides comprehensive safety assessment and genetic characterization support for the research, development, production and quality control of vectors such as AAV, lentiviruses and oncolytic viruses, helping enterprises and research institutions to overcome technical bottlenecks and accelerate the industrialization process of products.
Coverage of mainstream viral vector types
We focus on three key viral vectors and provide targeted testing services:
Targeting recombinant AAV vectors (such as serotypes AAV1-13), suitable for applications such as in vivo delivery and in vitro cell transduction in gene therapy;
Covering HIV-derived lentiviruses and integrated/non-integrated lentiviral vectors to meet the testing needs of cell therapy (such as CAR-T), gene editing and other fields;
Include adenoviruses, herpesviruses, poxviruses, and other oncolytic vectors, which support safety and efficacy testing in the development of anti-tumor drugs.
Next-Generation Sequencing (NGS) Technology Enables Precision Detection
Utilizing an industry-leading NGS technology platform, combined with customized library construction solutions and bioinformatics analysis workflows, we achieve comprehensive detection of viral vectors:
High coverage: Comprehensive capture of vector genome and exogenous pollutant sequence information
Accurate detection of multiple indicators : Simultaneously completes multiple indicators such as exogenous virus screening and sequence variation analysis;
Efficient process: From sample reception, nucleic acid extraction, library construction to data analysis, the entire process is standardized, shortening the testing cycle.
Dual -dimensional coverage of safety evaluation and genetic characterization
Extensive screening of exogenous contaminants is conducted for vector batches and key plasmids to ensure the safety of product clinical applications.
• Known exogenous factor detection: covers common contaminants such as mycoplasma, bacteria, fungi, and endogenous retroviruses (ERV);
• Unknown exogenous sequence screening: using metagenomic sequencing technology to discover potential unknown viruses or contaminants;
• Cross-contamination screening: Detect cross-contamination between different batches of carriers and between plasmids and carriers to ensure product purity.
Comprehensive genetic characterization of viral vectors and key plasmids ensures product consistency and stability.
• Vector genome integrity verification: Detecting the full-length vector sequence, the accuracy of target gene insertion , and mutation information ;
• Plasmid screening and identification: For key production plasmids (such as packaging plasmids and transfer plasmids), sequence correctness verification and contamination screening are performed;
• Genetic stability assessment: Monitor the genetic variation of vectors in different production batches to ensure consistency between product batches.
Integrating the entire process from R&D to production
Vector design optimization, plasmid screening and verification, and early safety assessment lay the foundation for subsequent experiments;
Batch quality control, process optimization support, and monitoring of external pollution sources to ensure compliance of the production process ;
Safety testing and genetic characterization reports that comply with GMP standards and meet regulatory reporting requirements;
Batch testing, quality release inspection, and long-term stability
Service Advantages – Professional, Efficient, and Customized
Extensive experience
Focused on the field of biomedical testing for many years, accumulating a large number of viral vector testing cases, adaptable to different application scenarios;
Technological leadership
Continuously iterating NGS detection technology and analysis algorithms to ensure the accuracy and reliability of detection results;
Compliance Support
The testing process complies with GLP/GMP standards, and the reports meet the application requirements of regulatory agencies such as NMPA, FDA, and EMA;
Customized services
Testing solutions can be adjusted according to customer needs, and personalized data analysis and interpretation support can be provided.