Next-generation sequencing (NGS) services empower the entire biopharmaceutical R&D and quality control process.
The animal-free NGS-based detection system overcomes the ethical and efficiency limitations of traditional in vivo and in vitro detection, enabling high-throughput gene characterization of cell banks, viral vectors, batch harvested products, and key raw materials. The detection results can directly supplement or replace the traditional in vivo detection process in viral safety strategies, providing data support for the compliance and scientific rigor of biopharmaceutical research and development.
Animal-free testing, GMP-standard services, and end-to-end processes provide professional and reliable gene sequencing solutions for the biopharmaceutical industry.
Animal-free
Detection is based on NGS technology, avoiding ethical issues related to animal testing and reducing costs.
GMP-level testing
GMP-compliant testing procedures covering six major application areas.
Full-process service
One-stop service from sample preparation to data analysis
Cell line analysis
Multi-dimensional cell line characterization including STR fingerprinting and insertion validation
Professional services
For AAV, lentivirus, and oncolytic virus vectors, we conduct NGS-based virus safety testing and plasmid screening, and perform extensive exogenous virus detection and genetic characterization on vector batches and key plasmids.
Covering 15,000+ viral sequences
GMP-grade NGS testing is suitable for precise quality control of cell therapy products such as CAR-T, CAR-NK, and iPSC.
Detection sensitivity > 98%
Whole-genome NGS analysis was performed to determine cell line characteristics and safety context, including STR fingerprinting and insertion validation.
Multi-angle and multi-dimensional assessment
CHO cell line characterization and virus safety testing accelerate the research and development process.
Reduce costs by 60%
Inactivated vaccines, recombinant vaccines, viral vector vaccines, and RNA vaccines are all covered, and batch release sequencing confirms genetic integrity.
Batch release sequencing
mRNA sequencing, ultra-rare variant analysis, and RNA integrity assessment, covering the entire stage of RNA therapy.
Full-stage support
Technological advantages
High-sensitivity detection
Detection limit reaches single copy level, ensuring accurate results.
GMP compliance
Complies with Good Manufacturing Practices for pharmaceuticals, ensuring data reliability.
High efficiency and cost-effectiveness
Can detect multiple targets simultaneously, reducing animal testing costs and lowering R&D investment and ethical risks.
Customized services
Customized testing solutions based on client needs, with flexible configuration.
Application Scope
It covers the entire biopharmaceutical R&D industry chain, including key links such as cell library construction, vector construction, antibody development, vaccine production, and RNA therapy R&D, serving biopharmaceutical companies, research institutions, CDMO/CMO and other partners.