Denarase®
GMP Serratia marcescens endonuclease for residual DNA removal in viral vector, vaccine and biologics manufacturing
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Denarase® is a recombinant Serratia marcescens endonuclease used for efficient removal of residual DNA and RNA in bioprocessing. Available in R&D- and GMP- grade, Denarase® supports process development through commercial manufacturing with comprehensive regulatory documentation and technical support.
Benefits of Denarase®:
- High activity to all forms of DNA/RNA
- Designed to support efficient nucleic acid clearance and competitive process economics
- Available in R&D- & GMP-grade with identical specifications
- Denarase® GMP-grade is produced under GMP conditions in accordance with EU GMP regulations
- Manufacturing free of animal derived materials and antibiotics
- Endotoxin-free expression host
- One-for-all Serratia marcescens ELISA Kit
- Comprehensive technical & regulatory support, e.g. drug master file for US-market approvals
Denarase® is a trusted endonuclease for residual nucleic acid removal, widely adopted by biopharma companies across development, clinical, and commercial manufacturing workflows. Customers rely on Denarase® for its proven performance, reliable supply, and comprehensive regulatory and technical support. For customers evaluating Denarase® as a new endonuclease or as an alternative to an existing nuclease, Kerry provides guidance documents to support qualification, process implementation and supplier change assessments.
Brochures
Frequently asked questions about Denarase enzymes
This resource addresses frequently asked questions about Denarase® enzymes. It covers general information, guidance on their use and application, key enzyme characteristics and differences, particularly in comparison with competitor products such as Benzonase®, as well as topics related to process integration and quality control.
Resource details:
Resource type: Product Brochure
Page count: 4
Read time: 7 mins
Guidance on how to qualify Denarase enzymes in biopharmaceutical manufacturing processes
The selection and qualification of raw materials, such as Denarase® and Denarase® High Salt, for biopharmaceutical manufacturing is a comprehensive and complex process. This product brochure supports customers in the qualification of Denarase® enzymes for the production of cell and gene therapy products and human vaccines, while outlining the support services provided by Kerry throughout the qualification process.
Resource details:
Resource type: Product Brochure
Page count: 6
Read time: 10 min
Guidance on change to Denarase in approved biopharmaceutical manufacturing processes
Denarase® is an endonuclease enzyme used in biopharmaceutical manufacturing to remove unwanted nucleic acids, making it a critical component of the production process. This product brochure supports customers transitioning from an alternative endonuclease to Denarase® in approved manufacturing processes as part of a post-approval change. It also outlines the support provided by the Kerry Biotechnology Center to facilitate an efficient and successful implementation.
Resource details:
Resource type: Product Brochure
Page count: 3
Read time: 5 mins
From endonuclease comparability challenges to harmonized activity testing: USP 〈89.3〉 General Chapter for endonucleases and its impact on the comparison of Denarase and Benzonase
The comparability of endonucleases is essential to secure supply chains, including dual sourcing strategies. To address this long-standing comparability challenge, the USP (United States Pharmacopeia) has released the General Chapter 〈89.3〉 Endonuclease (Serratia marcescens), introducing a harmonized framework for endonuclease activity determination. This marks an important step toward standardization of a critical ancillary material used in cell and gene therapy (CGT) manufacturing. In this study, the Denarase® activity release test developed by Kerry (formerly c-LEcta) for its Denarase® product is used, to compare activities of Denarase® and Benzonase®. By applying the Denarase® activity release assay test protocol to both enzymes, the correspondence of these results to the respective product's CoA values was evaluated.
Benzonase Nuclease is a registered trademark of Merck KGaA.
Resource details:
Resource type: Scientific Poster
Page count: 1
Read time: 4 mins
Product Overview
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