Quality and safety throughout the entire vaccine research and development and production process
NGS technology focuses on mainstream vaccine types such as inactivated vaccines, recombinant vaccines, viral vector vaccines, and RNA vaccines. With "batch release sequencing" as its core, it meets the quality control needs of the entire process of vaccine research and development, pilot production, and commercial release through precise genetic integrity confirmation and comprehensive quality characterization. It helps companies comply with global regulatory standards such as NMPA, FDA, and EMA, and ensures the safety, efficacy, and batch consistency of vaccine products.
Scope of Detection
We provide customized testing and characterization services for the mainstream technologies used in current vaccine research and production, covering various vaccine products.
Verification of inactivation efficacy, residual host cell nucleic acid, and screening for exogenous contaminants;
Verification of recombinant antigen protein sequences
Confirmation of vector genome genetic integrity, verification of the accuracy of target gene insertion, and screening for exogenous viral contamination;
RNA sequence integrity verification and full-length sequence accuracy confirmation.
Technical Service Content
• The genetic integrity of each batch of vaccine and ensure that there is no risk of sequence variation , contamination , or degradation during the production process ;
Technical solution: High-depth NGS sequencing technology is used, combined with standardized library construction and bioinformatics analysis workflow;
• Test content:
Sequence accuracy verification: Full sequence alignment analysis to screen for genetic variations such as point mutations, deletions, and insertions, ensuring that the vaccine target sequence is consistent with the design;
Genetic integrity verification: For viral vector vaccines/RNA vaccines, verify the integrity of the full-length genome/RNA, without truncation or degradation;
Contamination screening: Simultaneous testing for exogenous viruses, bacteria, mycoplasma, and other contaminants in batches to avoid cross-contamination;
Batch consistency analysis: Compare the sequence characteristics and quality control indicators of different production batches to ensure batch-to-batch stability;
• Comprehensive screening of exogenous contaminants: NGS metagenomic sequencing combined with traditional culture methods is used to detect contamination by bacteria, fungi, mycoplasma, and exogenous viruses (such as retroviruses and adenoviruses).
• Toxicity-related characterization: For attenuated vaccines/viral vector vaccines, assess their risk of virulence reversion and replication control to ensure safe clinical application.
Advantages of Testing Services
Full-scenario coverage
Adaptable to four major types of vaccines, meeting the quality control needs of the entire process from research and development to market launch, without the need for separate testing by multiple institutions;
Compliance assurance
Focusing on batch release sequencing, we provide regulatory-approved test reports to reduce declaration and release risks ;
High-efficiency empowerment:
shortens the testing cycle , supports rapid batch release for large-scale vaccine production, and accelerates the product launch process;
Professional support
A technical team composed of experts in vaccine research and development, molecular biology, and bioinformatics provides full-process solution design and data interpretation services.