Viral Vector Testing

Viral vectors are important tools used in gene therapy to deliver therapeutic genes into host cells, and testing of viral vectors is critical to ensure the safety, efficacy, and quality of gene therapy formulation development. CD Formulation provides accurate and reliable viral vector testing services for quality control of gene therapy formulations upon request to ensure the safety and efficacy of gene therapy formulations and help researchers facilitate gene therapy formulations' development.

The Importance of Viral Vector Testing

• Safety assessment. The safety of gene therapy is assessed by testing the purity and integrity of the viral vectors to ensure that they do not contain impurities or mutant viruses that may cause abnormal reactions in host cells.
• Efficacy validation. To assess the effectiveness of viral vectors in gene therapy by testing their functional properties, such as infectivity and gene delivery efficiency.
• Avoidance of immune response. Ensure proper handling of viral vectors to minimize host immune response to the vectors, thereby improving safety and efficacy in subsequent applications.
• Regulatory requirements. Viral vector testing of gene therapy formulations fulfills the requirements of regulatory agencies for quality control of gene therapy products to ensure that the product can pass the approval process.

Explore Our Gene Therapy Formulation Viral Vector Testing

Purity and Integrity Testing of Viral Vectors

The purity and integrity of viral vectors are important indicators for assessing their quality. We often use SDS-PAGE analysis, Western Blotting and other analytical methods to assess the purity and integrity of viral vectors.

Determination of viral vector titer

Viral titer refers to the concentration of viral vectors, including the total number of infectious viral particles and empty capsids. Our commonly used assays include quantitative reverse transcription PCR (RT-qPCR), enzyme-linked immunosorbent assay (ELISA), and flow cytometry (FC).

Bioactivity assay of viral vectors

The biological activity of viral vectors refers to their ability to infect target cells and deliver genetic material. We generally assess the infectious ability of viral vectors through infectivity assays. In addition to using reporter gene expression analysis, the activity of viral vectors is assessed by detecting the expression of reporter genes.

Replicative virus detection of viral vectors

Replicating viruses are viruses with self-replicating ability that may be produced during the production process, which poses a threat to safety. We often utilize the indicated cell culture method and PCR or q-PCR method to assess the presence of replicating viruses.

Genomic sequence integrity testing of viral vectors

The efficacy of gene therapy depends on maintaining the integrity of the therapeutic gene sequences delivered by viral vectors. Viral vector genomic sequence integrity is guaranteed by our cutting-edge sequencing method.

Our Process of Gene Therapy Formulation Viral Vector Testing

Sample preparation

Collect viral vector samples for proper dilution and pretreatment.

Physical characterization

Particle size and number analysis using nanoparticle tracking analysis (NTA) and other techniques.

Functional analysis

Evaluate the infection ability and gene expression of viral vectors using RT-qPCR and other methods.

Purity and integrity testing

Detect the purity and integrity of viral vectors by SDS-PAGE, Western blot and other methods.

RCL/RCR assay

Detect the presence of replicating viruses using methods such as indicated cell culture, ELISA, PCR/q-PCR or PERT.

Sequence validation

Confirmation of the integrity and accuracy of the viral vector genome sequence by Sanger sequencing or next generation sequencing (NGS) technology.

Quality control

Test results are analyzed to ensure that the quality of the viral vectors meets standards.

Fig.2 Viral vector testing process. (CD Formulation)

Our Technologies for Viral Vector Testing

Highlights of Our Viral Vector Testing

• Comprehensive testing services. We provide comprehensive testing services for quality control of gene therapy formulations, which greatly satisfy the various research needs of our clients.
• Technical expertise. We can provide accurate and reliable viral vector testing services for gene therapy formulations with a professional technical team and rich industry experience.
• High standard quality control. We conduct testing in strict accordance with industry standards and regulatory requirements to ensure the safety and efficacy of viral vectors.
• Customized solutions. We can provide customized testing services according to customers' needs, including the selection of testing items and optimization of testing methods.
• Advanced technology platform. We can have advanced laboratory facilities and the latest testing equipment to support high-precision testing services.

Published Data

CD Formulation provides customers with efficient, reliable and regulatory-compliant viral vector testing services to facilitate progress in the research and development of gene therapy formulations. If you are interested in us, please feel free to contact us.