Detection of Replication-Competent Adenovirus (RCA) and Replication Competent Retrovirus (RCR)

MDS offers testing services for detection of replication-competent adenovirus and replication competent retrovirus in compliance with FDA, ICH, and CPMP guidelines. A significant safety concern is the potential presence of RCR and/or RCA in retroviral or adenoviral vector-based gene therapy products, respectively. RCR and RCA may develop at any step during the manufacturing process of gene therapy products.

Replication Competent Adenovirus

Replication Competent Retrovirus (RCR) Detection