Moderator: Janet Macpherson, PhD, Royal Prince Alfred Hospital
- Michael Havert, PhD, FDA
- James Miskin, PhD, Oxford Biomedica
Viral vectors, particularly gamma retroviral and lentiviral vectors, are well suited to delivering genetic material to cells to offer therapeutic benefit. The wildtype viruses from which these vectors are derived, can replicate efficiently with a high recombination rate, hijacking the infected cells’ own replicative machinery. A conservative approach to prevent the unintended transmission of replication competent recombinant viruses (RCR/RCL), with potential to cause disease in patients has been adopted for over 25 years.
This session will highlight the current regulatory expectations for testing gene-modified patient cell products for RCR/RCL. The speakers will discuss benefits and limitations of the current technology in terms of the testing requirements, and provide some general guidance on permissible testing strategies, including post-release testing. Technology for the detection of RCR/RCL is evolving, to provide more rapid and more sensitive detection of the genetic material. Is this the future? What is the current status and what is the future of RCR testing?