E.coli Residual DNA Detection kit
beadHaibaorui Biotechnology Co., Ltd. has developed an E.coli residual DNA detection kit (PCR-fluorescence probe method), which can be used in conjunction with Baorui Biotechnology's nucleic acid extraction or purification kit (magnetic bead method), providing customers with an overall solution from extraction to detection.
Both the "Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (Trial)" and the "Technical Guidelines for Pharmaceutical Research and Evaluation of In Vitro Gene Modification Systems (Trial)" propose that process-related impurities are mainly introduced by the production process, such as host cell proteins, host cell DNA, host cell RNA, packaging plasmids, and endotoxins from viruses and bacteria used for packaging. It is necessary to establish reasonable quality standards and conduct release inspections.
The Chinese Pharmacopoeia clearly stipulates that the residual amount of DNA in biological products expressed by Escherichia coli should not exceed 10ng per dose.
The E.coli Residual DNA Detection kit from Baorui Biotechnology employs the PCR-fluorescence probe method. It designs primer probes for conserved sequences and uses ready-to-use calibrators to quantitatively detect the residual amount of target gene DNA in samples.
｜The reagent has excellent performance.
1. Quantification limit: 5 fg/μL.
2. Detection limit: 1fg/μL.
3. Repeatability (intra-analytical precision), intermediate precision (inter-instrument, inter-day, inter-personnel, inter-reagent batch) and reproducibility (total imprecision), with a quantification limit CV≤20%, and a CV≤15% for medium and high concentrations.
Eight genomes, including Acidophilus, Propionibacterium, HEK293, MDCK, BHK21, Vero genome, CHO genome and Pichia pastoris genome, do not interfere with this kit.
｜Convenient and fast operation
1. Extraction only requires three steps; The amplification time is only 90 minutes.
2. Calibrators do not need to be diluted, and the finished products can be assembled conveniently and quickly.
The entire test can be completed in as fast as 2 hours。
The UDG enzyme anti-contamination system is adopted to effectively avoid the risk of contamination of amplification products.
1. Freeze-thaw stabilityThe kit was repeatedly frozen and thawed 3, 5, 7 and 10 times, and the performance of the reagents was not affected.
2. Instrument applicability
The performance is not affected on different models of devices such as ABI 7500, ABl QuantStudio™ 5, Bio-Rad CFX96, SLAN-96P, SLAN-96S, Roche Light cycler 480 Ⅱ, etc.
E.coli Residual DNA Detection Kit (PCR-Fluorescence Probe Method)
Item Number: BP-QN24-100
Nucleic Acid Extraction or Purification Kit I (Magnetic Bead Method)
Item Number: BP-QN01-100/48/32
Nucleic Acid Extraction or Purification Kit II (Magnetic Bead Method)
Item Number: BP-QN11-100/48/32
Nucleic Acid Extraction or Purification Kit III (Magnetic Bead Method)
货号：BP-QN36-100/48/32 BP-QN40-48
"Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Products in Vivo (Trial)"
2. Technical Guidelines for Pharmaceutical Research and Evaluation of In Vitro Gene Modification Systems (Trial)
3. Chinese Pharmacopoeia
4. United States Pharmacopeia
5. European Pharmacopoeia
6. "Guiding Principles for Validation of Analytical Methods
