Replication Competent Virus Testing Quantitation
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
rcAAV-2/N Quantitation Kit
rcAAV-5/N Quantitation Kit
Types of Replication Competent AAV Assays Quantitation
Virus DNA & RNA Extraction Kit
Replication-Competent Lentivirus (RCL) Quantitation Kit
Replication-Competent Retrovirus (RCR) Quantitation Kit
rcAAV-2/N Quantitation Kit
rcAAV-5/N Quantitation Kit
Regulatory Testing Requirements
USP: 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.
Shentek technology co ltd stands as a leading brand committed to delivering top-tier QC solutions for the biopharmaceutical industry. Our range of standardized and customized quality control products is designed to meet the needs of various cell species and manufacturing processes. We have successfully supported thousands of customers throughout their entire product life cycle, from research and development to IND and BLA filing, production, and release. Our unmatched expertise in designing and validating QC methods empowers customers to tackle even the most challenging projects.
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