Residual DNA testing services

With our expertise and extensive experience in the “Gold-standard” real-time qPCR assay development and validation, Avance Biosciences offers customized residual DNA analysis services to determine the residual host cell DNA in biological products derived from cell substrates.  Our custom-designed GMP/GLP compliant qPCR method offers a powerful tool to address the safety concerns and satisfy the requirements for regulatory agencies worldwide.
Residual DNA Testing services are frequently used for raw material testing, lot release testing, final product release, and cleaning validation.

Services

Avance Biosciences offers three types of residual DNA testing assays to detect and quantify host DNA contaminants in biologics products developed from human, monkey, pig, mouse, CHO, chicken, insect, yeast and E. coli cell lines.
Service Description
Residual DNA testing by dilution Dilution method is used when the level of DNA contamination is unknown or for samples from early stage of protein purification. Serial dilutions are performed on each testing samples and controls before qPCR analysis.
Residual DNA testing by extraction Extraction method is frequently used when DNA contamination is known to be in pg/ml range, or testing samples demonstrate PCR inhibition, or the level of DNA contaminants is below the testing limit of the dilution method.
Residual DNA testing for sizing Custom designed assays targeted in various length of PCR amplicons profile the length distribution of host DNA contaminants in a biologics product.

Features

  • Custom qPCR assay design and validation
  • Rigorous measures to prevent cross contamination between samples
  • Separate PCR rooms used to prevent contamination from environment
  • Wide dynamic range in testing limits covering 5 log range
  • Validated ABI 7900HT platform used for testing
  • Methods are validated per ICH guidelines

Deliverables

  • A report with following information will be delivered:
  • Summary of the assay
  • Results of the quantification
  • Tabulation of raw qPCR data
  • Turn Around Time
  • 1 week for routine batch release testing (for existing assays)
  • 4 weeks for assay development, validation, and testing

 

Need more info?

Contact Us

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.

Ready to get started?

Request A Quote

Give us a little background on your needs and the goals of your project, and we’ll send a preliminary quote including: tasks, deliverables and a no-obligation cost estimate.