Replication competentlentvirus/retrovirus (RCL/RCR) are capable ofintegratinginthe genome and may confer long-term effects, for example, the risk of insertional mutagenesis, potentially leading to cancer. Coinfection of a cell with both rcAAV and a therapeutic AAV vector may affect the conversion of single-to double-stranded genomesin the presence of adenovirus, and may alsolead to mobllization of the vector upon adenovirusinfection.
Virus DNA & RNA Extraction Kit
Replication-Competent Lentivirus (RCL) Quantitation Kit
Replication-Competent Retrovirus (RCR) Quantitation Kit
USP: <1047>GENE THERAPY PRODUCTS
EP: 5.14.Gene transfer medicinal products for human use
FDA: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy lnvestigational New Drug Applications (NDs) Guidance for lndustry.
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Guidance for Industry.
EMA: Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.
ChP: ChP 2020, Volume lll. General Principle of Gene Therapy Products for Human Use.
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