Fapon enzymes
High-quality enzyme products fueling your research and industrial applications
Strict adherence to ICH guidelines ensures the enzyme purity and functionality
Process-related impurities control: Safeguarding the purity and safety from the source
With strict adherence to ICH guidelines, we control potential enzyme process-related impurities (EPRI) throughout production. The impurities may come from:
Cell matrices: Host cell proteins, host cell DNA
Cell cultures: Inducers, antibiotics, media
Downstream processes: Processing reagents, column precipitate
We employ sophisticated technologies to identify, assess, and conduct qualitative and quantitative analyses of impurities to ensure the safety and purity of every batch of our enzyme products.
No | Enzyme process-related impurities (EPRI) | Specifications |
|---|---|---|
1 | Nucleic acid contamination | The sensitivity is 0.1 copy/μL as determined by TaqMan-based qPCR. (E.g., No more than 2 copies of E. coli genomic DNA are detected with 100 units of Taq polymerase.) |
2 | Endonuclease nicking assay | A reaction incubated at 37℃ for four hours results in less than 10% (5 supercoiled plasmids) conversion to open circular plasmids as determined by agarose gel electrophoresis. |
3 | Exonuclease contamination assay (dsDNA 3' overhang, dsDNA 3' recessed, dsDNA blunt end, ssDNA) | No less than 95% of the substrate RNA remains intact as determined by capillary electrophoresis. |
4 | Single- stranded DNase assay | No less than 95% of the substrate RNA remains intact as determined by capillary electrophoresis. |
5 | RNase residue testing | The relative fluorescence units (RFU) at the 30 mintues of reaction are less than< 2 × RFU at the 0 minute of reaction as detected by the microplate reader. |
6 | Alkaline phosphatase assay | K (sample slope) is less than 3 × K (blank slope). |
7 | Non-specific DNase activity | A reaction containing λDNA incubated at 37℃ for 16 hours results in a DNA pattern free of detectable nuclease degradation as determined by agarose gel electrophoresis. |
8 | Protein purity | No less than 98%. |
Functional indicators: Perfect fit your experimental demands
We choose specific enzyme functional indicators (EFI) for different enzymes, such as:
Taq polymerase: Amplification sensitivity, amplified fragment length
Other enzymes: Specificity, thermal stability, reaction rate, error rate
The indicators ensure superior performance of our enzymes to support your research and industrial applications.
Impact and quality control of impurities: Safeguarding your experiments
Impurities in enzyme products may reduce enzyme activity and stability, compromise experimental results, increase production costs, and even pose potential risks to both the environment and human health.
We strictly control the production processes to prevent the introduction of contaminants (such as microorganisms and bacterial endotoxins), ensuring the high quality and reliability of our products.
Partner with us in pure, efficient and stable enzymes!
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