Provinase®: GMP Endonuclease for DNA Clearance in Vaccine Production and Cell & Gene Therapy

Provinase®: GMP Endonuclease for DNA Clearance in Vaccine Production and Cell & Gene Therapy

As the biopharmaceutical industry evolves with increased focus on vaccines, viral vectors and cell & gene therapies, regulatory scrutiny on product purity continues to intensify. Among the key quality concerns is the presence of residual host cell DNA (HCD), which must be effectively removed to meet stringent global regulatory requirements.

Regulatory agencies including the WHO, US FDA, EMA and Chinese Pharmacopoeia limit residual DNA to nanogram levels per dose, with strict thresholds like ≤10 ng/dose for products expressed in E. coli or yeast, and ≤3 ng/dose for Vero cell–derived vaccines. Such guidelines make DNA clearance an essential step in bioprocessing.

Provinase®, a GMP-grade recombinant endonuclease from Provis Biolabs, is designed for robust and reliable removal of nucleic acid contaminants. Developed using animal-origin-free processes and manufactured under strict quality systems, Provinase® supports manufacturers in achieving high product purity, safety and compliance.

Why Provinase®?

High Activity, Broad Substrate Specificity Provinase® degrades all forms of DNA and RNA, including single- and double-stranded, linear, circular forms. It works efficiently under diverse conditions, simplifying integration into various upstream and downstream processes.

GMP Grade | Animal-Origin-Free | Antibiotic-Free Manufactured under GMP guidelines and free from animal or antibiotic components, Provinase® meets the expectations of global biopharma regulatory authorities for biomanufacturing inputs.

Reliable Supply & Regulatory Support Available with a detailed Certificate of Analysis, TSE/BSE statements and technical support, Provinase® is suitable for commercial-scale manufacturing. Drug Master File (DMF) support can be provided upon request.

Applications of Provinase®

• Viral Vector Purification: Enhances purity and safety in AAV, lentivirus and other viral vector platforms
• Protein and Vaccine Manufacturing: Reduces viscosity and improves yield by degrading nucleic acids during lysis and purification
• Cell & Gene Therapy: Ensures clearance of host and plasmid DNA in critical therapeutic workflows
• Prevents Cell Aggregation: Minimizes clumping in culture by reducing extracellular nucleic acid content

Product SKUs & Formats

Provinase® is available in the following standard activity units:

• 100 KU
• 500 KU
• 1 MU
• 5 MU

Custom pack sizes and bulk options are available upon request.

Frequently Asked Questions

Q: When should Provinase® be added in the process? A: Add it post-lysis during clarification or directly to lysate. Ensure Mg2+ is present at optimal levels for activity.

Q: Is Provinase® inhibited by salts or buffers? A: High concentrations of Na+, K+, guanidine, or phosphate (>500 mM) may inhibit activity. Chelators like EDTA reduce Mg2+ availability, impacting enzyme function.

Q: Is it compatible with protease inhibitors? A: Yes, but EDTA-free formulations are recommended to preserve activity.

Q: How can Provinase® be removed post-use? A: Via standard purification steps such as ultrafiltration, chromatography or TFF.

Q: Is Provinase® patent-restricted? A: No. Provinase® is free from patent constraints, enabling flexible use across platforms.

Need Samples?

Samples of Provinase® (R&D or GMP grade) are available for evaluation.

📧 Contact us at: customersupport@provisbiolabs.com

Storage & Handling

• Storage Temperature: -20°C
• Shelf Life: 24 months
• Handling: Avoid repeated freeze-thaw cycles; aliquoting is recommended