QPCR biodistribution study

With our expertise and extensive experience in the “Gold-standard” qPCR assay development and validation, Avance Biosciences offers comprehensive qPCR biodistribution study designed to determine the distribution of gene therapy vectors in intended and distant tissues.  Our custom-designed GLP complied qPCR biodistribution study assays offer a powerful tool to address the safety and efficacy concerns and satisfy the requirements for regulatory agencies worldwide.

Service Description

A typical QPCR biodistribution study assesses the presence of gene therapy vectors in a panel of tissues collected at multiple time points ranging from a few days to several months post administration. The panel of tissues typically includes blood, heart, brain, liver, kidney, bone marrow, ovaries/testes, lung, draining lymph nodes, spleen, and muscle samples at the site of administration.

  • Sample received and assigned unique accession number(s)
  • In-process samples also assigned unique tracking number(s)
  • All samples stored in freezers with temperatures continuously monitored
  • Extraction method validated for each tissue with high-spike, low-spike, and no-spike controls
  • Target specific assay developed and optimized with and validated per ICH guidelines
  • Tissues processed with controlled procedures designed to prevent cross contamination
  • Nucleic acids isolated in designated Biosafety Level II extraction laboratory
  • Nucleic acid concentration determined with Nanodrop
  • Separate clean rooms free of nucleic acids used to prepare master mixes and negative controls
  • Separate template room used to handle sample and positive controls
  • PCR reactions performed on validated ABI 7900HT platform
  • Standard curve generated to determine copy numbers

Features

Below are typical characteristics of Avance Biosciences’ qPCR biodistribution study services. Actual numbers may vary and will be derived from custom validation.

  • 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

Deliverables

  • Normalized target quantity are reported as the number of vector copies detected per genome detected
  • As low as 50 copies per reaction is routinely detected
  • Report reviewed by QA unit and signed by QA representative and study director
  • Final report issued including: description of assay, results of the quantification, and tabulation of data
Contact our customer service to request for more information or obtain a no-obligation quotation.

 

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