Description
Pichia pastoris Host Cell DNA Residue Detection Kit is used for the quantitative analysis of Pichia pastoris host cell DNA residuce in intermediate samples, semi-finished and finished products of various biological products.
This kit adopts Taqman fluorescent probe and the polymerase chain reaction (PCR) method, which has fg level minimum detection limit and can specifically and quickly detect the residual Pichia pastoris cell DNA. The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES).
Feature
- Compliance with regulations: the products are fully validated according to the requirements of Chp, USP, ICH, etc., and their performance is in line with Chinese and foreign regulations and standards;
- Guarantee of quality: the raw materials of the kits are all self-developed, and the qPCR Mix and other enzyme products are produced in an ultra-clean enzyme factory;
- High sensitivity: the limit of quantification can reach 3 fg/μL level;
- High precision: high intra-batch repeatability and low inter-batch variation;
- Strong exclusivity: specific detection of residual DNA in Pichia pastoris cells without interference from other exogenous genomic DNA;
- Strong anti-interference: add internal control (IC), easy to exclude sample interference, reaction preparation abnormalities and other factors.
Application
Residual Pichia pastoris Host Cell DNA test in biological products.
Specification
|
Sensitivity |
3 fg/μL (range 30fg/μL~300pg/μL) |
|
Assay Time |
~1.5 hours |
|
Assay Principle |
Fluorescent probe qPCR method |
|
Required Instruments |
Real-time fluorescence quantitative PCR system |
Components
|
Components No. |
Name |
41328ES50-EN |
41328ES60-EN |
|
41328-A |
Pichia pastoris qPCR Mix |
0.75 mL |
1.5 mL |
|
41328-B |
Pichia pastoris Primer&Probe Mix |
200 μL |
400 μL |
|
41328-C |
DNA Dilution Buffer |
1.8 mL×2 |
1.8 mL×4 |
|
41328-D |
Pichia pastoris DNA Control (30 ng/μL) |
25 μL |
50 μL |
|
41328-E |
IC* |
50 μL |
100 μL |
*IC：Internal control.
Storage
This product should be stored at -25~-15℃ for 2 years.
Both 41328-A and 41328-B should be stored protected from light.
Figures
Limit of quantification
Pichia pastoris DNA was detected at 30 fg/uL, 10 fg/uL, 3 fg/uL, and 1 fg/uL with 10 replicates for each concentration. The results showed that at concentrations of 3 fg/uL and above, the CV was <20%, i.e., the limit of quantification of Pichia pastoris host cell DNA residues was 3 fg/uL.
|
Test item |
Pichia pastoris DNA (fg/uL) |
|
|
Quantity |
Return ratio |
|
|
1 |
3.83 |
127.76 |
|
2 |
3.68 |
122.53 |
|
3 |
2.55 |
85.05 |
|
4 |
2.66 |
88.63 |
|
5 |
3.74 |
124.63 |
|
6 |
3.29 |
109.54 |
|
7 |
3.04 |
101.42 |
|
8 |
3.54 |
118.1 |
|
9 |
3.09 |
102.91 |
|
10 |
3.27 |
109.01 |
|
Average value |
3.27 |
\ |
|
CV% |
13.49% |
\ |
Table 1. Limit of quantification (LOQ) assay results for Pichia pastoris DNA
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