Viral Vector Analysis
Reproducible data are key to science. To make sure viral vectors are of the highest quality, undertaking a rigorous quality control (QC) process is important. Viral vectors, such as Adeno-associated virus (AAV) vectors, Lentiviral (LV) vectors, Adenovirus (Ad) vectors, Herpes Simplex Virus (HSV) vectors, Vaccinia virus (VACV) vectors have diverse applications, spanning from direct in vivo gene delivery in genetic therapies to in vitro transduction for gene-modified cell therapies like CAR-T, and even in oncolytic applications. Owing to their high transfection efficiency and the ability to obtain target cells that stably express foreign genes, they have gradually shown certain advantages in cell and gene therapy. However, translating promising research into clinical development faces a significant challenge in establishing suitable viral vector analysis methods for characterizing clinical-grade viral vectors. Creative Biolabs has focused on full-scale QC test methods of viral vectors to ensure the safety and efficiency of viral vectors.
SERVICE
Creative Biolabs has established multiple advanced viral vector analytical testing platforms to ensure your product to move as quickly and safely as possible. We provide tailored QC testing solutions, customized to factors like the viral vector type and application requirements. Our offerings encompass a wide range of options, including but not limited to:
Identity tests can be conducted to ensure the existence and identity of the viral vector.
The viral vectors’ titer, represents the concentration of viruses with infective capability in a given solution volume. Determining the titer of viral vectors can help determine their activity and concentration, which is crucial for determining the appropriate dosage and ensuring therapeutic effectiveness.
Demonstrating the absence of microbial contamination in the vector product is critical to ensure parenteral product safety. Such testing should include assays for sterility, mycoplasma, endotoxin, and general safety.
Potency, also known as biological activity, is the essential quality parameter of viral vectors. Assessing viral vector potency comprehensively involves performing various assays, including titer assays and assessments of empty particle-to-whole particle ratios. Additionally, infectivity and cellular potency assays, which include evaluations of transgene expression and functional assays in host cells, are conducted to gain a comprehensive understanding.
Ensuring that viral vector samples are free from impurities, cellular residues, or other contaminants is essential to guarantee the safety and purity of the product. Impurities in viral vectors can trigger immune responses, impacting the assessment of viral vector potency.
Tab.1 The specific analysis components of the viral vectors.
| Viral Vector Analysis | ||
|---|---|---|
| Category | Test Items | Methods |
| Identity | Appearance | Visual inspection |
| Osmolality | Osmometry | |
| pH | Potentiometry | |
| Aggregate formation | Dynamic Light Scattering (DLS) | |
| Vector genome identity | DNA sequencing | |
| Serotypes | Western blotting and ELISA | |
| Titer | Physical titer | qPCR, ddPCR, ELISA, FACS |
| Biological titer | Viral plaque assay, Immunoassay, TCID50, | |
| Safety | Sterility | Bioburden |
| Endotoxin | LAL | |
| Bioburden | Plate count method | |
| Mycoplasma | Gel, qPCR | |
| Immunological responses | Western Blot, ELISA | |
| DNA integration & risk of carcinogenicity | LAM-PCR | |
| Potency | Vector copy number (VCN) | qPCR, dPCR |
| Empty Capsid Rate | Analytical Ultra Centrifugation (AUC) | |
| In vitroexpression | In vitro transduction/ELISA | |
| Purity | Residual protein | SDS-PAGE, ELISA |
| Residual DNA | Q-PCR | |
| Residual nuclease | ELISA | |
| Residual cesium | Mass spectrometry | |
We recognize that every experiment necessitates specific quality standards, and our team of virologists and QC engineers is committed to providing a robust analytical testing protocol tailored to your requirements. Please contact us for full services.
