Viral Vector Characterization
As cell and gene therapy field continues to push products through the clinical landscape, the need to develop appropriate analytical tools has become increasingly evident. Because of their intended use in patients, gene therapy products must meet rigorous safety guidelines highlighting the importance of well-characterized analytics. For cell and gene therapy, one critical aspect of the supply chain is the vector used to introduce the gene of interest. Most commonly, viral vectors, derived from lentivirus (LV), adenovirus (AV) or adeno-associated virus (AVV) are used for these therapeutics. One of the challenges of viral vector characterization and quality control testing is its high complexity. Even the recombinant adeno-associated virus (rAAV), the smallest and least complex recombinant viral vector, has a more complex structure than the most complex recombinant protein. The key to developing large-scale, optimized production, harvesting and purification strategies to meet the needs of viral vectors is to have accurate and reproducible analysis tools to monitor quality attributes to ensure safe, high-quality, consistent and effective products.
Overall solution
Due to the complexity of biological manufacturing of viral vectors, there may be variability in the manufacturing process, so it is necessary to characterize the products in the process to ensure consistency between batches. Gene therapy products must meet strict safety guidelines to highlight the importance of well-characterized analysis. CD BioSciences offers the following viral vector characterization services to meet the specific needs of different customers.
Our service items
| Quality | Attribute | Technique |
|---|---|---|
| Identity | Confirm presence and identity of viral vector | SDS-PAGE, Mass spectrometry (MS), Western blot (immunoblot), Genome sequencing (NGS), PCR |
| Potency | Physical viral titer | DNA hybridization, Real-time PCR (qPCR, ddPCR), NanoSight, HPLC |
| Functional viral titer | Plaque-forming assay, Fluorescence foci assay, TCID50 (end point dilution assay) | |
| Purity | Host cell-related Impurities |
Host cell DNA/RNA: DNA Threshold assay, qPCR, Host cell proteins: ELISA, TEM |
| Capsid content (empty: full capsids) | TEM, AUC | |
| Safety | Sterility | Standard sterility tests |
| Endotoxin | LAL method | |
| Mycoplasma | PCR, Cell cultured based-assays | |
| Replication Competent Virus | Southern blotting, qPCR | |
| Stability | Osmolality | Osmometry |
| Aggregate formation | Light microscopy, DLS, SEC-MALS, TEM, AUC, FFF-MALS | |
| pH | Potentiometry |
Our advantages
- First-class expert technical team: The team is professional and experienced.
- Our well-trained, friendly and professional research supervisors and project managers will complete your project on time through open communication channels and meet your requirements.
- Our team works with scientists, quality assurance/quality control professionals and project managers from many pharmaceutical and biotechnology companies and organizations around the world, and has a wealth of knowledge and experience.
- Professional after-sales service: A professional after-sales team is set up to provide customers with practical and feasible solutions efficiently and quickly.
Our service items
| Project name | Viral vector characterization |
|---|---|
| Our services |
|
| Product delivery mode | We will complete the project on time according to the agreed time, summarize the experimental data and conclusions, and complete the experimental report. |
| Price | Inquiry |
Why choose us?
CD BioSciences provides professional viral vector characterization to meet the needs of regular customers to identify hits on time and on budget. CD BioSciences relies on world-class cell engineering technology expertise, we provide customers with the best quality one-stop viral vector characterization, including the development of experimental programs according to different experimental needs. Please feel free to contact us for more detailed information, our scientists will tailor the most reasonable plan for your project.
