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Replication-Competent AAV Testing

Replication-incompetent vector particles derived from AAV (adeno-associated virus) have been shown to mediate transfer and expression of heterologous genes (transgenes) into a variety of cells in vivo and in vitro. It has tremendous potential in both research and therapeutic applications.

While AAV vectors are engineered to be replication defective, generation of replication-competent AAV (rcAAV) can still occur during vector manufacturing by means of recombination events within the producer cells. rcAAV may develop at any step during the manufacturing process of gene therapy products. Even though vector production systems have been specifically developed to reduce the risk of rcAAV generation, there is still a significant safety concern driving the recommendations for testing for rcAAV in cell banks, vector and final product release for AAV-based gene therapy products.

The presence of rcAAV in clinical lots of AAV vectors raises a variety of safety concerns:

  1. The potential presence of rcAAV in retroviral or adenoviral vector-based gene therapy products
  2. Influence the behavior of these vectors both in cultured cells and in animals
  3. In vivo recombination with endogenous AAV sequences
  4. Unintended vector replication due to the presence of wild-type helper function

Creative Biogene offers testing services for detection of rcAAV in compliance with FDA, ICH, and CPMP guidelines. We have established a method to detect rcAAV more sensitively and rapidly. With years of experience in biosafety assessment, we can design a customized testing program to assess the potency, purity, and safety of your viral vaccine or gene therapy product at phase-appropriate levels (R&D, GLP, and GMP) to support your regulatory filing.


  1. R&D studies
  2. GLP/GMP submissions
  3. adeno-associated viral vector-based gene therapy programs


  1. Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).
  2. Allen et al. 1997. Identification and Elimination of Replication-Competent Adeno-Associated Virus (AAV) That Can Arise by Nonhomologous Recombination during AAV Vector Production. Journal of Virology. 6816-6822.

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