Gene Therapy Formulation Host RNA Residue Testing

RNA residues may affect the biological activity (e.g. interfering with plasmid transfection, expression efficiency, etc.) or pose a risk (e.g. immune response triggered by activation of cellular interferon pathway by exogenous RNA), so it is critical to test gene therapy formulations for host cell-derived RNA residues to ensure product quality. CD Formulation specializes in the development of gene therapy formulations, and we provide professional testing and QC service programs for gene therapy formulation development and manufacturing.

The Importance of Gene Therapy Formulation Host RNA Residue Testing

• Ensure product quality. Host RNA residues may affect the purity and quality of gene therapy products, and testing can ensure product quality and safety.
• Avoid immune response. Residual RNA may activate the cellular interferon pathway, triggering an unwanted immune response, which is potentially harmful to human health.
• Safeguard biological activity. During the preparation of plasmid DNA, host RNA residues may reduce the purity of the DNA product and affect its biological activity, such as interfering with the transfection and expression efficiency of the plasmid.
• Reduce risk. Quantitative detection methods, such as quantitative reverse transcription PCR, can accurately determine the amount of exogenous RNA residues, reducing the risk of RNA residues.

Explore Our Gene Therapy Formulation Host RNA Residue Testing

Our methods for host RNA residue testing

• Agarose gel electrophoresis method. This method is characterized by ease of operation by separating RNA molecules of different sizes by electrophoresis and visualizing and analyzing them using stains.
• High-performance liquid chromatography (HPLC). Uses the difference in retention time of different RNA molecules in liquid chromatography for separation and quantitative analysis. We have specialized equipment and technology to support the application of this technique to host residual RNA.
• Reverse transcription polymerase chain reaction (RT-qPCR). By designing specific primers and probes, RNA is reverse transcribed into cDNA and then analyzed by real-time quantitative PCR. This technique has demonstrated high sensitivity, specificity and accuracy in host residual RNA detection.
• RNA fluorescence quantification method. Using fluorescence-labeled probes to specifically bind to RNA molecules, the content of RNA is quantitatively analyzed by measuring the intensity of the fluorescent signal.

Sample suitability verification

Sample suitability validation, together with a comprehensive kit performance validation report, ensures the accuracy and credibility of test results.

• Precision (Repeatability, Intermediate Precision) Validation.
• Sample recovery (accuracy) validation.

Sample testing

Sample extraction (magnetic bead method), automated extraction with supporting equipment to meet high throughput requirements and ensure extraction efficiency.

• Residual RNA detection.
• Provide RNA residue data and sample recovery data in samples.

Fig.2 Our process of host RNA residue testing. (CD Formulation)

Our Technologies for Gene Therapy Formulation Host RNA Residue Testing

Highlights of Our Gene Therapy Formulation RNA Residue Testing

• We have advanced and compliant testing equipment to ensure stable and accurate test results.
• We have a team of experts with many years of gene therapy formulation development, which can provide reliable quality control testing services.
• We have a standardized testing process, which can reduce systematic errors between experimental batches.
• We can provide customized host residue RNA testing services according to the needs of our client's projects to ensure that our client's research needs are met to the greatest extent possible.

Published Data

CD Formulation provides comprehensive and reliable quality control support for gene therapy formulation development based on years of research experience and advanced technology platform. We want to help you advance your gene therapy formulation development and ensure product safety and reliability. If you are interested in us, please feel free to contact us.