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
  • Identity testing service
  • Potency testing service
  • Purity testing service
  • Safety testing service
  • Stability testing service
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.
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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.

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