As a CRO specializing in antibody discovery and cell-based immunotherapy, Creative Biolabs has established several world-leading platforms to serve worldwide clients with academic or clinical requirements. Now, we are proud to offer a replication-competent virus testing service for gene-mediated cell therapy and viral vector-based gene therapy programs. Of note, this service will definitely help move the viral vector-based therapy into the clinic more quickly.
Viral vectors have been widely applied in clinical trials including gene therapies and gene-mediated cell therapies for a variety of inherited and acquired diseases. Despite the powerful usage, there is a challenge to move any viral vector into the clinic since the possibility of the presence of replication-competent lentivirus (RCL) or replication-competent retrovirus (RCR) limits this progress. Therefore, during manufacturing these vectors, it is a key factor to test for the replication-competent virus which may have been produced through recombination during the various stages of vector preparation and ex vivo patient treatment. While assay development for RCL/RCR is also particularly challenging. Fully understand the needs and importance, scientists from Creative Biolabs provide the testing service to ensure patients are not inadvertently exposed to replicating virus.
We are capable of performing the RCL/RCR testing abiding by the FDA guidance. Firstly, it was asked for a minimum of 5 passages on a permissive cell line. Then, at least 5% of the cell supernatant or 300 mL (whichever is less) needs to be tested. Meanwhile, at least 1% of the total cells or 108 cells (whichever is less) need to be evaluated. On one hand, for RCR testing, we can detect the gibbon ape leukemia virus (GaLV) and murine leukemia virus (AMULV, XMULV, and EMULV). Both cell co-cultivation test and supernatant amplication would be conducted in HEK 293 cells or Mus dunni cells. Moreover, PG4 S+L- focus assay and XC plaque assay would be flexible options for customers. On the other hand, for RCL testing, either cell co-cultivation test or supernatant amplication would be conducted with C8166 cells. Besides, VSV-G qPCR endpoint could be performed upon request. All of these tests can be finished around 2 months.
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With years of experience, Creative Biolabs can deliver a wide range of contract research services that are tailored to their individual requirements in terms of science, timelines, and cost. For more interests in our services, please feel free to contact us to discuss your specific requirements.
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