With consideration of the accrued scientific evidence of safety associated with retroviral vector design and testing, we are revising our current recommendations for RCR testing during retroviral...

guidelines recommended by FDA for detecting RCR. In a typical assay for detecting RCL associated with HIV-1 based vectors, the test article is used to inoculate a cell line (C8166-45 derived from human umbilical cord blood lymphocytes) that is permissive for infection and growth of HIV-1, and the transduced cell line is

2023年3月9日 · The assay needs to be tailored for the parent virus (e.g., MLV, HIV-1) and vector pseudotype (envelope). The FDA has recommended a minimum of five cell passages (approximately 3 weeks) of culture to identify slow-growing viruses. Table 1 provides a list of detection methods used in RCR assays.

FDA recommends that the MCB be screened using a sensitive cell culture-based RCR detection assay. A working cell bank (WCB) may be established and tested before the vector production step. Less extensive testing is required for a WCB. To manufacture a retroviral vector lot, seed vials from either a working cell bank or a master cell bank are

2018年9月21日 · Replication-competent retrovirus (RCR) is a safety concern for individuals treated with retroviral gene therapy. RCR detection assays are used to detect RCR in manufactured vector, transduced cell products infused into research subjects, and in the research subjects after treatment.

Replication Competent Lentivirus (RCL) Assay: This assay is designed to detect replication competent lentivirus (RCL) derived from HIV-1 based vectors. The test sample is used to inoculate a cell line, C8166-45 (derived from human umbilical cord blood lymphocytes), that is permissive for infection and growth of HIV-1.

MDS offers a panel of sensitive tests to detect infectious murine retroviruses. Our procedures can detect viruses from the four classes of these retroviruses originally isolated from mice that are of concern for various biological products.

2022年7月21日 · In response to the growing demand for viral vector-based, replication-competent assays, we’ve developed a new RCR assay to help determine the safety and efficacy of cell and gene therapies.

2018年8月17日 · Replication-competent retrovirus (RCR) is a safety concern for individuals treated with retroviral gene therapy. RCR detection assays are used to detect RCR in manufactured vector, transduced cell products infused into research subjects, and in the research subjects after treatment. In this study, w …

RCV testing encompasses sophisticated analytical methods designed to detect and quantify replication-competent lentivirus (RCL) or replication-competent retrovirus (RCR) in gene therapy products. The testing process involves multiple complementary techniques, all working together to identify any virus particles that may have regained their ...