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.

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).