SuperNuclease, a potent endonuclease derived from Serratia marcescens, is designed to efficiently degrade residual nucleic acids in biological products.
Drug regulatory authorities in various countries have established stringent limits on the residual nucleic acids in biological products. For example, the FDA mandates that the residual DNA in biologics derived from host cells should not exceed 100 pg per dose. At the same time, the European Pharmacopoeia requires that residual DNA in biologics be below 10 ng per dose. Therefore, it is essential to eliminate residual nucleic acids during production to meet these regulatory standards.
The amount of remaining host cell DNA was significantly reduced by nuclease treatment of the lentiviral supernatant.SuperNuclease is typically used to extract host nucleic acids from biological products; however, in the preparation and purification of some biological products, like those used in gene and cell therapy, it tends to lose activity under high concentrations of salt.
Salt Active SuperNuclease retained high activity under high salt concentration conditions, while SuperNuclease lost its activity.After three months of storage at 25 °C, enzyme activity remained unchanged, according to real-time stability data.Specific activity of different salt-tolerant nucleases Test conditions: 20 mM Tris-HCl, 37 °C, pH 8.5. Image Credit: Sino Biological US Inc.
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Regulatory-Compliant Nucleic Acid Removal Biologics
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