Potency of Viral Vector
Potency serves as the quantitative gauge of biological activity tied to the pertinent biological traits of viral vectors. Assessing potency is pivotal as it should mirror the Mechanism of Action (MoA) of the medicinal product, ideally aligning with clinical outcomes. To fully characterize the viral vector potency, Creative Biolabs performs tests such as vector copy number (VCN), and empty particle-to-whole particle ratios. In addition, we offer infectivity and cellular potency assays, including transgene expression and functional assays in host cells.
- Vector Copy Number (VCN)
In gene therapy, achieving the desired level of transgene expression is crucial for therapeutic efficacy. Monitoring the vector VCN helps ensure that the appropriate genetic dose is present in the target cells. Factors such as viral dosage, cell type, and the design of the expression cassette can influence the efficiency of gene transfer and ultimately impact the VCN achieved in gene-modified cells. Therefore, VCN measurement serves as a direct indicator of how effectively the therapeutic gene has been delivered into the target cells and is essential for optimizing gene therapy approaches and maximizing therapeutic outcomes.
We utilize both qPCR and Digital PCR (dPCR) to determine VCN. dPCR is a robust method for accurately measuring nucleic targets with precision and reproducibility, eliminating the need for a standard curve or reference to interpret overall quantity.
- Empty Particle to Full Particle Ratio
In the process of viral vector preparation, except for the complete viral vector containing a full-length DNA genome, a certain percentage of viral particles do not contain any DNA genome, which is called empty viral particles. The presence of a large number of empty viral particles may affect the effectiveness and safety of viral vectors and cause cellular immunotoxicity.
We apply a range of methods, including cryo-transmission electron microscopy (cryo-TEM), volume exclusion chromatography (SEC), and analytical ultracentrifugation (AUC), to efficiently determine total and infectious particle counts.
- Infection Efficiency Test In vitro expression
Infection efficiency testing typically involves incubating viral vectors with target cells in vitro and monitoring the expression of the protein of interest using various methods, such as immunofluorescence staining or flow cytometry. The efficiency of viral transduction is assessed by quantifying the proportion of cells that express the protein of interest.
SERVICES
Leveraging our vast expertise and cutting-edge technology, Creative Biolabs presents comprehensive characterization programs aimed at evaluating the potency of viral vectors, guaranteeing a top-tier product for your needs. Reach out to us for further details regarding viral vector potency testing, and we'll gladly provide assistance tailored to your requirements.
