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 study 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.
Avance Biosciences offers qPCR biodistribution study 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?
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?
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.