Adenovirus Biodistribution

Adenoviruses have been widely used in gene therapy for a variety of applications, owing to their diversity and efficiency in delivering therapeutic DNA cassettes to the nuclei of cells in vitro and in vivo. More than 400 gene therapy trials have been or are being performed with adenovirus vectors. As a pioneer company in the field of gene therapy, Creative Bioarray is capable of offering Adenovirus Biodistribution analysis service in the most high-quality and cost-effective way. And we focus on the RNA ISH assay that can provide single-cell AAV biodistribution data for every tissue type.

As stated by the USFDA, "The biodistribution data, coupled with other preclinical safety endpoints such as clinical pathology and histopathology, help determine whether vector presence or gene expression correlates with any tissue-specific detrimental effects in animals." (FDA Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products, November 2013). This is particularly important in germ-line tissues (i.e., gonads) to determine intertied transmission status. Our AAV distribution services can help you accelerate your gene therapy development.

Adenovirus Biodistribution Tests Available:


  • Genome Copy Titer
  • Transduction Efficiency
  • Effectivity
  • Potency Assay Development


  • Pharmacodynamics
  • Safety/Toxicology
  • Biodistribution and Shedding
  • Immunogenicity


  • Clinical GLP Bioanalysis
  • Potency Release Assay

Product Approval

  • Clinical GLP Bioanalysis (LTFU)
  • Potency Release Assay

One of the key aspects of the safety of adenovirus vectors in gene therapy and vaccination is to ensure that the vectors remain localized to the target tissues and do not spread to other tissues or organs, which can lead to unintended side effects. Therefore, it is important to detect and quantify the biodistribution of adenovirus vectors following administration. Biodistribution studies provide information on the distribution of the vector in various tissues and organs, which can help you identify any potential safety concerns.

Existing studies are generally limited to organ-level resolution without examining other routes of administration. The Adenovirus Biodistribution (RNA ISH assay) Services from Creative Bioarray provides an unparalleled sensitive and specific method for cell and tissue-specific assessment of gene therapy vector and transgene expression analysis in any tissue.

Quotation and ordering

Our customer service representatives are available 24hr a day! We thank you for considering Creative Bioarray as your Adenovirus Biodistribution Analysis Service partner.


  1. EMEA. (2009) General principles to address virus and vector shedding, in ICH Considerations, EMEA/CHMP/ICH/449035/442009.
  2. EMEA. (1997) Preclinical safety evaluation of biotechnologicy-derived pharmaceuticals S6, in ICH harmonised tripartite guideline.
  3. EMEA. (2009) Addenedum to ICH S6: Preclinical safety evaluation of biotechnologicy-derived pharmaceuticals S6(R1), in ICH draft consensus guideline.
  4. Schenk-Braat, E. A., van Mierlo, M. M., Wagemaker, G., Bangma, C. H., and Kaptein, L. C. (2007) An inventory of shedding data from clinical gene therapy trials, J Gene Med 9, 910–921.
  5. Stieger, K., Schroeder, J., Provost, N., Mendes-Madeira, A., Belbellaa, B., Le Meur, G., Weber, M., Deschamps, J. Y., Lorenz, B., Moullier, P., and Rolling, F. (2009) Detection of intact rAAV particles up to 6 years after successful gene transfer in the retina of dogs and primates, Mol Ther 17, 516–523.
  6. Manno, C. S., Pierce, G. F., Arruda, V. R., Glader, B., Ragni, M., Rasko, J. J., Ozelo, M. C., Hoots, K., Blatt, P., Konkle, B., Dake, M., Kaye, R., Razavi, M., Zajko, A., Zehnder, J., Rustagi, P. K., Nakai, H., Chew, A., Leonard, D., Wright, J. F., Lessard, R. R., Sommer, J. M., Tigges, M., Sabatino, D., Luk, A., Jiang, H., Mingozzi, F., Couto, L., Ertl, H. C., High, K. A., and Kay, M. A. (2006) Successful transduction of liver in hemophilia by AAV-Factor IX and limitations imposed by the host immune response, Nat Med 12, 342–347.
  7. Toromanoff, A., Cherel, Y., Guilbaud, M., Penaud-Budloo, M., Snyder, R. O., Haskins, M. E., Deschamps, J. Y., Guigand, L., Podevin, G., Arruda, V. R., High, K. A., Stedman, H. H., Rolling, F., Anegon, I., Moullier, P., and Le Guiner, C. (2008) Safety and efficacy of regional intravenous (r.i.) versus intramuscular (i.m.) delivery of rAAV1 and rAAV8 to nonhuman primate skeletal muscle, Mol Ther 16, 1291–1299.
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