DMF #036779


GMP-Grade All-Purpose Nuclease

Multipurpose Nucleic Acid Degradation

The various types of biological products and pharmaceutical drugs are expanding rapidly. Simultaneously, biological products also have a strict quality control system, among which residual nucleic acid is a key focus of drug regulatory agencies. Products such as AAV vectors, antibody drugs, vaccines, and recombinant protein drugs are expressed and produced by continuously passaged cells. Even after a fine purification process, host nucleic acids may remain in the products, and the residual nucleic acids may cause pathogenicity, tumorigenesis, etc. risk. Additionally, CAR-T cell therapies, lentivirus therapies, protein extraction industries all need to strictly control the residue of nucleic acid.

GMP-Grade Enzymatic Degredation

At present, the methods for nucleic acid removal mainly include enzymatic hydrolysis, polyethyleneimine (PEI) precipitation, ion exchange chromatography, etc. Our MaxNuclease™️ uses enzymatic degradation, which is widely favored due to its high efficiency, economy, and easy operation. KACTUS MaxNuclease™️ has been developed and verified with reference to cGMP production standards. The manufacturing process is in accordance with GMP production standards to ensure the traceability of raw materials in the production process. At present, this product has also been filed with the U.S. FDA Drug Master Files (DMF #036799).


→ Removal of nucleic acid (DNA/RNA) residues in biological products
→ Purification of viral vaccines and viral vectors such as lentivirus, recombinant adenovirus, oncolytic virus, etc.
→ Reducing the viscosity of cell lysates and cell supernatants
→ Preparing samples in western blot analysis, 2D gel electrophoresis, ELISA, and chromatography to improve resolution and recovery

Quality Standards

→ Activity (Dissolve herring sperm DNA): ≥ 250 U/µL
→ Purity (Bis-Tris): ≥ 95%
→ Purity (SEC-HPLC): ≥ 99%
→ Residual Protease: Negative
→ Endotoxin: ≤ 0.01 EU/kU
→ Residual Host Protein: ≤ 10 ppm
→ Sterility: Negative
→ Residual Heavy Metal: ≤ 10 ppm
→ Mycoplasma: Negative

Product Validation

MaxNuclease™️ added to PCR product, genomic DNA, and plasmid DNA shows comparable degradation activity of nucleic acids to leading competitors.

MaxNuclease™️ ELISA Kit

After the nucleic acid is removed by MaxNuclease™️ for biological products such as viral vectors and vaccines, it is also necessary to evaluate the residue of MaxNuclease in the system. To this end, Kaijia Biotech has carefully developed a highly sensitive and specific residue detection kit, MaxNuclease ELISA Kit, with a sensitivity of up to 23 pg/ml.

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