RCR Assays

The possible presence of replication competent retroviruses (RCR) in gene therapy products intended for human use remains a major safety concern.  RCR’s can develop at any step during manufacturing. Additionally, the growth of ex vivo- transduced cells provides the potential for amplification of any RCR contaminant, which can be below the level of detection in the retroviral vector supernatant.  The current recommendations include testing of material from multiple stages of product manufacturing. MDS offers amplification and co-cultivation assays for RCR detection.