rcAAV testing

Preparations of AAV vectors may be contaminated with rcAAV, commonly known as wild-type. These rcAAV are formed through homologous or non-homologous recombination events between AAV elements present on the vector and AAV rep and cap sequences that are introduced during the manufacturing process. While wild-type AAV is not known to be pathogenic and cannot replicate without a helper virus, the expression of cap or rep genes in infected cells can lead to unintended immune responses, potentially diminishing effectiveness and posing unforeseen safety risks. Therefore, we strongly advise testing for rcAAV, which has the potential to replicate in the presence of a helper virus, and including these results in the IND report.

NikeBio offers rcAAV testing services that align with FDA, ICH, and CDE guidelines. Our advanced method enables the sensitive and rapid detection of rcAAV. Leveraging our extensive experience in biosafety assessment, we can design tailored testing programs to assess the efficacy, purity, and safety of your viral vaccine or gene therapy product at different stages (R&D, GLP, and GMP), providing the necessary support for your regulatory submissions.