Detection of exogenous viruses is a critical quality control step in the development of gene therapy formulations. Exogenous viruses may originate from various sources, including raw materials used in the production process, cellular matrix, operating environment, etc. Therefore, ensuring the safety and efficacy of gene therapy products requires strict detection and control of exogenous viruses. Therefore, to ensure the safety and efficacy of gene therapy products, stringent testing and control of exogenous viruses is required. CD Formulation provides comprehensive technical support in the development of gene therapy formulations, especially for quality control including exogenous virus testing. Our testing process includes exogenous virus screening, exogenous virus identification and virus removal to minimize the impact of viruses on gene therapy formulations to ensure that the target product meets quality standards and regulatory requirements.

The Importance of Gene Therapy Formulation Exogenous Virus Testing

Exogenous virus testing is essential to ensure the safety, efficacy and quality control of gene therapy products and is an indispensable part of the gene therapy field. The importance of exogenous virus testing will be further emphasized with the development of technology and the improvement of regulatory requirements.

• Ensure product safety. Gene therapy products that are contaminated with exogenous viruses may pose a health threat to patients. Therefore, testing for exogenous viruses is a basic requirement for ensuring patient safety and a prerequisite for guaranteeing the safety of gene therapy formulations.
• Compliance with regulatory requirements. Regulatory agencies around the world require rigorous testing of biologics for exogenous viruses to ensure product safety. Compliance with these regulations for exogenous virus testing is critical for the subsequent approval and promotion of gene therapy formulations.
• Maintaining product quality. Contamination with exogenous viruses may affect the quality of gene therapy products, and by detecting and controlling exogenous virus contamination, product consistency and reliability can be assured.

Explore Our Gene Therapy Formulation Exogenous Virus Testing

Real-time PCR (qPCR) assay

• We use qPCR assay to detect the presence of infected exogenous viruses in gene therapy formulations.
• We can target different sources of viral factors and detect DNA residue levels with high sensitivity, high throughput, high efficiency, and high accuracy through our specialized sample pre-treatment and qPCR assays.

Cell culture method

We apply cell platform or let culture method in exogenous virus detection, and strictly follow the corresponding norms and standard operation procedures to ensure the accuracy and reliability of the test results, our main process is shown below.

• Determine the appropriate cell line.
• Preparation of samples.
• Add sample.
• Observe and record.
• Analyze and confirm.

Due to the complex preparation process and lyophilization, we also need to optimize and validate different biologics according to their characteristics.

Digital PCR (dPCR)

• Exogenous viruses can be detected using dPCR. Based on the characteristics of dPCR, it can make up for the shortcomings of qPCR technology, as follows.
• The ability to directly count the copy number of the target sequence without relying on a reference standard curve.
• Meager copy numbers can be detected.
• More tolerant to inhibitory substances in the sample.

Next-generation sequencing (NGS)

Adopting NGS technology has the advantages of high sensitivity, high specificity, multiplex detection, no need for a priori knowledge, and high throughput. However, there are many potential problems, such as sequencing errors, contamination. We can misinterpret, etc., so it is necessary to follow a strict standardized procedure to ensure the accuracy and reliability of the test results. The main processes we use when utilizing sequencing methods for exogenous virus detection are shown below.

• Establishment of a library for virus detection.
• Sequencing and data analysis.
• Verification and validation.

Our Technologies for Gene Therapy Formulation Exogenous Virus Testing

Highlights of Our Gene Therapy Formulation Exogenous Virus Testing

• We offer a comprehensive range of exogenous virus testing services with an experienced team of expert technicians and state-of-the-art laboratory equipment.
• We offer comprehensive performance validation services for customized assays and sample testing using a wide range of state-of-the-art methodologies.
• We provide GMP-compliant NGS solutions for exogenous and specific virus detection, viral vector and plasmid identification services.
• We provide end-to-end services including research packaging, process development, analytical method development, cGMP manufacturing, and testing services.
• We can provide one-stop gene therapy formulation development and testing solutions according to customers' requirements, to maximize the satisfaction of customers' all-round needs.

Published Data

CD Formulation can utilize qPCR, cell culture method, dPCR, NGS and other methods to detect exogenous viruses in the developed gene therapy formulations and issue appropriate test reports. We ensure the reliability and accuracy of our tests and look forward to working with you in good faith. If you are interested in us, please feel free to contact us.