- Nuclease clearance verification in final drug substance and drug product - Process-related impurity testing during biopharmaceutical purification - Release testing for nuclease-treated biological products - Validation of nuclease removal steps in downstream processing
Product Overview :
This kit uses a double-antibody sandwich ELISA format for quantitative determination of universal nuclease (Serratia marcescens endonuclease) in biopharmaceutical samples. It offers high detection sensitivity and a broad linear range, and is suitable for detecting recombinant Serratia marcescens nuclease.
Features & Benefits :
- High sensitivity enables detection of trace-level nuclease residuals - Broad linear range accommodates samples with varying nuclease concentrations - Specific for recombinant universal nuclease with minimal cross-reactivity - Supports process validation studies per regulatory agency expectations