Gene Therapy Formulation Host DNA Residue Testing

During the production of gene therapy agents, host residual DNA may be generated, which, if not completely removed, may negatively affect the quality and purity of the gene therapy formulation and may even be harmful to human health. CD Formulation offers host residue DNA testing services to ensure the purity and safety of gene therapy formulations. This important process not only helps researchers meet regulatory standards but also ensures the safety of their products, thereby gaining the trust of their customers. We can provide customized host residue DNA testing support based on the needs of your project to ensure the accuracy of any contaminating DNA in the development and production of your gene therapy formulation, simplifying your path to compliance.

The Need for Gene Therapy Formulation Host Residual DNA Testing

• Potential tumorigenicity. The main oncogenic mechanism of residual DNA is the introduction of dominant oncogenes, which can directly transform normal cells, causing some cells to differentiate into tumorigenic cells. Other oncogenic mechanisms may be the insertion of residual DNA in the host cell causing mutations, resulting in the inactivation of oncogenes and the activation of proto-oncogenes into oncogenes.
• Potentially infectious. For example, residual DNA may carry some viruses that can amplify and produce infectious viral particles through replication and transcription.
• Potential to trigger immune side effects. Genomic DNA of microbial origin increases the risk of immunogenicity of gene therapy formulations in vivo because it is rich in CpG and unmethylated sequences.

Explore Our Gene Therapy Formulation Host DNA Residue Testing

Southern blot-like hybridization

We detect the presence of a fragment in a DNA sample that is homologous to a probe and the length of that fragment by immobilizing the DNA sample on a solid-phase carrier and hybridizing it to a labeled nucleic acid probe. The technique can be used to determine the size of DNA fragments from complex genomic DNA mixtures and allows relative quantitative analysis to determine the copy number of fragments present in the genome.

Quantitative PCR (qPCR)

This is a method that monitors fluorescence signals while PCR amplification is taking place, and can be used for both absolute and relative quantification. qPCR technology is characterized by high sensitivity, specificity and automation. qPCR enables quantitative analysis of exogenous DNA by designing specific primers and probes with fluorescent labels, and by real-time monitoring of fluorescence changes during PCR amplification.

Digital PCR

Determines the absolute copy number of DNA by measuring the proportion of negative parallel samples, with the advantages of no need to rely on reference substances or standard curves, and highly resistant to inhibitors. Digital PCR technology can provide an absolute quantitative index that informs the selection of sampling methods, thereby improving detection rates.

Fluorescent staining method

Utilizes a specific fluorescent dye to bind to double-stranded DNA, and the fluorescence intensity is proportional to the DNA concentration to achieve quantitative detection. This method is easy to operate, but care needs to be taken to avoid fluorescence quenching and background interference.

Immunofluorescence

Based on the principle of antigen-antibody reaction, fluorescently labeled antibodies are used to detect specific antigens in cells or tissues. This method can be used for quantitative and localization analysis, but requires high-quality antibodies and repeated optimization of experimental conditions.

We provide optimal solutions according to the characteristics and requirements of our customers' projects. In general, qPCR is more often used for the detection of residual DNA quantification and has shown good detection results.

Our Technologies for Gene Therapy Formulation Host DNA Residue Testing

Highlights of Our Gene Therapy Formulation Host DNA Residue Testing

• We can ensure the safety of the gene therapy formulation being developed and help researchers meet regulatory standards.
• We can provide customized host residue DNA testing to support gene therapy formulation development and research based on the needs of the client's project.
• We can accurately measure any contaminating DNA in the development and production of gene therapy formulations.
• We can validate the performance of your samples to ensure compliance with regulatory requirements and provide a full validation report.

Published Data

CD Formulation has many years of experience in gene therapy formulation development, and we can maximize your research efforts in gene therapy formulation development. If you are interested in us, please feel free to contact us.