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Advanced Therapy Medicinal Products (ATMP) are

  1. Gene Therapy Medicinal Products which contain a recombinant nucleic acid to regulate, repair, replace, add or delete a genetic sequence.
  2. Somatic Cell-Based Therapies to substantially manipulate cells or tissues for the prevention or treatment of a metabolic or immunologic disease.
  3. Tissue Engineered Products to regenerate, repair or replace a human tissue.
  4. Combination of a medical device with ATMP.

Non-clinical studies for cell-based medicinal products (CBMP) should also comprise biodistribution studies to characterize the kinetics, migration and persistence of cell-based products. If the CBMP expresses a systemically active biomolecule, the excretion and/or the distribution of this API should also be studied in vivo.

Accelero Bioanalytics provides sensitive qPCR assays to quantify human CBMPs in animal tissues sampled in your biodistribution study.
Accelero also provides species-specific and sensitive RTqPCR assays to monitor the expression of your human transgene in host tissues of choice.

GLP compliant qPCR is required for biodistribution studies.

Quantitative real-time polymerase chain reaction (qPCR) is the method of choice for the detection and quantitation of specific gene sequences or vectors in biodistribution studies. qPCR is a highly sensitive, analytical method for determining whether a nucleic acid (DNA or RNA) target is present in tissues. Extracted DNA is assayed directly, while RNA is reverse transcribed into cDNA.
Accelero Bioanalytics performs qPCR assays for biodistribution studies in accordance with Good Laboratory Practice (GLP) regulations. The levels of DNA of interest are evaluated using a validated qPCR method. During the validation process, the following parameters are assessed to ensure that the method is reproducible, accurate and sensitive:

  • Sensitivity
  • Specificity (may be <100 copies per microG host gDNA)
  • Precision and accuracy
  • Stability
  • Dilution linearity
  • DNA isolation from tissues
  • Matrix effects

Each qPCR study has multiple assay controls to confirm the optimal performance of the assay and to confirm the absence of reagent contamination and qPCR inhibitors, thereby ensuring that reproducibility, sensitivity and accuracy are achieved.




Last update of this site: 25-OCT-2016 by Christian Lange

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