Product Application Scenarios

1. Removal of Residual Nucleic Acids in Biologics: During the production of biologics, such as viruses, vaccines, and proteins,UltraNuclease can be added to degrade residual nucleic acids. This step not only increases the yield of viruses but also significantly reduces the content of residual nucleic acids, thereby ensuring the safety and efficacy of the drugs.
2. Viscosity Reduction: By degrading nucleic acids, the viscosity of cell lysates is reduced, which facilitates filtration/ultrafiltration processes during the purification of cell-derived particles such as viruses, AAV vectors, and inclusion bodies.
3. Improved Resolution and Recovery: In ELISA, two-dimensional electrophoresis, and immunoblotting analyses, it improves resolution and recovery.
4. Prevention of Cell Aggregation: UltraNuclease can effectively prevent the aggregation of human peripheral blood mononuclear cells (PBMCs).

To explore the optimal operating conditions for UltraNuclease, we studied the effects of various buffering systems on enzyme activity.

Comparative analysis of competing products (from A company)

The performance of the UltraNucleaseis consistent with Company A, and it can achieve a replacement effect.

The quality inspection standard conforms to the GMP production standard

To match the use of UltraNuclease, Yeasen has also independently developed a specific detection kit for the UltraNuclease, which can effectively detect residual enzyme and reduce risks. The Yeasen UltraNuclease Residual Detection Kit was developed in reference to the 2020 Chinese Pharmacopoeia <9101> Analytical Method Validation Guidelines, and strictly follows the key requirements for multi-parameter testing (linear range, specificity, accuracy, precision, sensitivity, accelerated stability, etc.).

Residual UltraNuclease Detection

In normal purification steps, UltraNuclease is easily removed as impurities. In order to detect the specific residual amount of omnipotent UltraNuclease, it is often used as a standard product in the industry and a matching ELISA kit is developed.

The UCF.ME® UltraNuclease ELISA Kit independently developed by Yeasen adopts the principle of double-antibody sandwich enzyme-linked immunoassay (sandwich ELISA), which can accurately detect the residual amount of UltraNuclease in samples. The kit is stable in linearity, repeatability, recovery rate and specificity.

Principle of Yeasen UltraNuclease ELISA Kit (Two-site immunoenzymetric assay)

Product Features:

Regulatory Compliance: Fully validated according to regulatory requirements, validation reports are available; Quality Assurance: All raw materials for the kit are independently developed, ensuring quality control;

High Sensitivity: Quantitative limit as low as 23.5 pg/mL;

High Precision: High intra-batch repeatability and low inter-batch variability;

Strong Specificity: No cross-reactivity with other engineered cell proteins

Performance parameters:

Product data:

 Reagent kit standard curve:

Actual sample recovery experiment:

UltraNuclease was spiked in 5 μg/mL cell lysis solutions (HEK293, E.coli, CHO, and Vero) independently with a final spiked conc. of 1.5 ng/mL. The accuracy in different cell samples showed excellent than other vendor.

Specificity demonstration

Conclusion: The test kit has high specificity with no cross-reaction; pairwise comparisons, “*” Significant difference from Negative sample; “NS” No significant difference from Negative sample.

Repeatability:

Conclusion: 6 duplicated were tested at each concentration on the standard curve, and all the CV% were lower than 5%.

Intermediate precision:

3 analysts conduct the UCF.ME™ UltraNuclease ELISA experiment and the CV% were lower than 15%

Product Information:

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