Residual DNA Testing

Are you required by the FDA to test the amount of host cell DNA (residual DNA) in your new biologics drug? Are you planning to replace your current Threshold assay with a real-time qPCR method for GMP lot release?  Check out Avance Biosciences' residual DNA testing services. You can choose our standard or custom-designed real-time qPCR assays to test residual DNA of E. coli, CHO, NS0, and many other species.

 

Real-time qPCR

Real-time qPCR assay is replacing Threshold as the method of choice for residual DNA testing. Compared to the Threshold assay, real-time qPCR has the following advantages:

    • Specific only to host cell DNA
    • Broader range of detection
    • High throughput
    • Not limited to only one supplier
    • Lower cost

Our Service

  • Validated methods
  • GMP compliance
  • Fast turn-around time
  • Custom assay development and validation
  • Technology transfer available

Testimonials

Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects. –Program Manager, California


 

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We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a quick message with your questions to find out what Avance can do for you.

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