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Home>Testing and Inspection Technology Platform>Testing and Inspection Technology Platform>Replication-competent Lentivirus (RCL) Testing
During the production of lentiviral vectors, recombination may occur between the shuttle vector, packaging vector, and endogenous reverse transcription elements in the packaging cells, or between the viral vector and endogenous reverse transcription elements in the cells, potentially generating replication-competent lentiviruses (RCL). Given the potential threat of RCL, both FDA and European Union have issued related documents, requiring RCR/RCL control at various stages of production and application, including cell banks used for virus production, final cells, viral vectors, transduced cells, and monitoring of patients following CAR-T cell infusion.
Sensitive Cell Co-culture Assay
Samples with potential RCL risk are amplified on sensitive cells and then tested using sensitive and rapid detection methods (such as ELISA p24 protein assay, Q-PCR, and Product-Enhanced Reverse Transcriptase Activity Assay (PERT)) at the designated endpoint.
HIV-1 attenuated strains are used as positive control viruses for the RCL assay, with negative controls, positive controls, and inhibition controls set up to verify the applicability of the reaction system and monitor the assay's sensitivity.
The RCL testing method has been validated and can meet the testing needs for different types of samples.
Main Regulatory References
"Quality Control Testing and Non-Clinical Research Considerations for CAR-T Cell Therapy Products," China National Institute for Food and Drug Control, 2018
"Technical Guidelines for Pharmaceutical Research and Evaluation of In Vitro Gene Modification Systems (Trial Version)," Center for Drug Evaluation, National Medical Products Administration, 2022
"Technical Guidelines for Pharmaceutical Research and Evaluation of Immune Cell Therapy Products (Trial Version)," Center for Drug Evaluation, National Medical Products Administration, 2022
Guidance for Industry: Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up ，FDA，2020
Guidance for Industry: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) ，FDA，2020
EUROPEAN PHARMACOPOEIA 10.0
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