• Biodistribution

    In vivo Biodistribution studies are required by regulatory agencies to evaluate the safety and toxicity of gene therapy vectors. Avance Biosciences offers GLP compliant QPCR services to accurately assess the quantity of gene therapy vectors in target and non-target tissues.

    Biodistribution
     
Your regulatory submission project is so important to you and your organization that it is critical to select a reliable service provider for your crucial biodistribution study project. Avance Biosciences has the technical expertise, GLP regulatory compliance, fast turn-around time, and outstanding customer service to ensure the success of your project.

Select a Vendor

Consider the following points when you are ready to select a vendor for your qPCR biodistribution project:

  • Is the vendor GLP complied? Ask for a copy of its quality manual.
  • Perform an on-site quality audit or, at the minimum, perform a paper audit with a complete GLP quality questionnaire.
  • Does the the vendor develop and validate qPCR methods for GLP applications per ICH guidelines?
  • How does the vendor manage customer samples to ensure the integrity of precious preclinical samples?
  • Does the vendor’s price proposal include items for target-specific assay development and validation, including DNA extraction efficiencies tests for all sample types?
  • Has the vendor done similar work before? Check if the vendor’s lead study director or study manager has the experience and reputation in the industry. A quick linkedin profile search will do the trick.
  • Avoid “black-box” organization where no information is communicated until the project is done, or in big trouble.
  • Lastly, it is always a good idea to send the vendor a pilot project with a few samples to evaluate its technical capability, report format, regulation compliance, and quality of customer service.

Key Features

Avance Biosciences offers qPCR biodistribution service with the following characteristics:

  • Limit of Detection: 5-10 copies of vector/1 μg of genomic DNA
  • Sensitivity: 10-100 copies of vector/1 μg of genomic DNA
  • Linearity range: 10 to > 107 copies/1 μg of genomic DNA
  • Accuracy: ± 0.25 log10
  • Precision: ≤10% CV
  • Specificity: Positive and Negative controls will be tested
  • Normalized target quantity are reported as the number of vector copies detected per genome detected
  • Final report issued including: description of assay, results of the quantification, and tabulation of data
  • Most experienced staff in the industry
  • Weekly report on project progress
  • Open communication between our study directors and clients

 

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.

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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.