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Replication-Competent Adenovirus Testing

Adenoviral vectors have the potential to be extremely valuable tools for human gene therapy. It has been used to infect many mammalian cell types (both replicative and non-replicative) for high expression of the recombinant protein. Recombinant adenoviruses are especially useful for gene transfer and protein expression in cell lines. During adenovirus vector production, particles may be generated which are replication competent through recombination with host sequences or by contamination. The probability of producing replication competent adenovirus (RCA), although low, increases with each successive amplification. Therefore, development of a sensitive assay for detection of replication-competent recombinant adenoviruses in large-scale Ad5-based vector preparations is needed.

The major safety concerns regarding adenovirus vector manufacture and clinical use are listed below:

  1. The possibility of adenovirus infection
  2. Unintended vector replication due to the presence of wild-type helper function
  3. Exacerbation of host inflammatory responses

Creative Biogene offers biosafety testing in support of gene therapy clinical products performed at multiple stages during the production process. Based on years of experience and in-depth investigation, scientists at Creative Biogene can provide a quick and complete system to detect replication-competent adenovirus in compliance with FDA, ICH, and CPMP guidelines in your viral prep.

1. Routine CPE detection assay
As a method to detect RCA in adenovirus vector products, CPE assay is recommended by the FDA [1]. In the cell culture/CPE assay, the vector products are infected into cells, the RCA are amplified, and the CPE induced by the RCA is observed.

2. Quantification of RCA by real-time quantitative PCR
Besides the routine CPE detection assay, Creative Biogene has established a method to detect RCA more sensitively and rapidly. This method allows RCA to be quantified by real-time quantitative PCR using primers and a probe designed for E1 DNA [2].


  1. Viral vector-based gene therapy programs
  2. GLP/GMP platform


  1. Guidance for human somatic cell therapy and gene therapy (2001). Hum. Gene Ther.12: 303–314.
  2. Ishii-Watabe A, Uchida E, Iwata A, et al. Detection of replication-competent adenoviruses spiked into recombinant adenovirus vector products by infectivity PCR[J]. Molecular Therapy, 2003, 8(6): 1009-1016.

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