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.
Email: info@shentekbio.com
Telephone:
US Mobile: +1-908-822-3199
US Office: +1-800-960-3004 ext 720
China Office: +86-400-878-2189
Address:
USA site: 3350 Scott Blvd Bldg 6, Santa Clara, CA 95054
China site: No.1366 Hongfeng Road, Huzhou, Zhejiang, China, 313000
info@shentekbio.com 
English
日本語
한국어
français
Deutsch
Español
العربية
