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E.coli Total RNA Residual (qPCR) Detection Kit
DNA products represented by plasmids/Minicircle DNA serve as key components of DNA vaccine products and essential raw materials for viral or non-viral vector gene therapies and cellular immunotherapies. RNA residues in these DNA products may interfere with their biological activity (e.g., disrupting plasmid transfection and expression efficiency) or pose risks (e.g., exogenous RNA activating cellular interferon pathways to trigger immune responses). Therefore, it is critical to establish a quantitative method for detecting RNA residues in DNA products.
This kit, equipped with E.coli RNA quantitative reference materials, enables rapid and accurate quantification of E.coli (DH5α, BL21, etc.) host cell RNA residues in intermediate, semi-finished and final biological products.
Compliance Validation:
Comprehensive validation conducted in accordance with Chp, USP, ICHQ2(R1) and other requirements, with performance meeting both domestic and international regulatory standards.
Contamination Prevention: dUTP + UNG enzyme system prevents aerosol contamination.
High Specificity:
Designed primers and probes targeting high-abundance, dispersed (recurrent) RNA sequences in E. coli. Utilises reverse transcription PCR principles for specific detection of residual E. coli RNA, unaffected by exogenous DNA or RNA interference.
Quality Assurance:
All kit components are independently developed. Manufactured in GMP-compliant facilities with stable production processes and controlled batch-to-batch variation.
Audit-Compliant:
Operates under ISO13485 quality management systems with comprehensive audit documentation.
Exceptional Durability:
Demonstrates outstanding freeze-thaw stability. Kit components maintain full functionality after five freeze-thaw cycles and are compatible with multiple qPCR instruments, including the ABI 7500 Real-Time PCR System, Bioer 9600 FQD-96A and Bio-Rad CFX Opus 96 Real-Time PCR System, etc.
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