Product/Service

Residual DNA Testing

Residual DNA Testing
The company's Molecular Biology department has over ten years of experience testing biological materials for the presence of residual DNA.
The company's Molecular Biology department has over ten years of experience testing biological materials for the presence of residual DNA. Offering several state-of-the-art hybridization assays as well as Threshold testing, the company provides clients with high quality residual DNA testing services.

The experience base includes detection of DNA originating from diverse species of prokaryotic and eukaryotic origin. Products tested are commonly derived from natural sources (e.g. blood products, bone, cartilage) and genetically modified materials (e.g. recombinant protein expressed in mammalian cells, insect cells, E. coli). Testing methods are also applicable to vaccines and therapeutic products based on gene therapy.

The company recently optimized all critical parameters of hybridization assays, dramatically improving the reproducibility and quality of the assay results. These assays are fully validated to fulfill ICH regulatory guidelines, including precision, accuracy/specificity, limit of detection, range, linearity, and ruggedness.

Program Features

  • Regulatory Compliance
  • Species of DNA Detected
  • Assay Sensitivity
  • Reproducibility
  • Alternative Methodology

ViroMed Biosafety Laboratories, Residual DNA Testing, 1667 Davis St., Camden, NJ 08104. Tel: 800-622-8820. Fax: 609-342-8078.