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Understanding EndoCleave's role in viral vector manufacturing

EndoCleave - a high-quality and efficient endonuclease during the biopharma production process

EndoCleave is a high-performance wild-type (wt) endonuclease enzyme designed to selectively degrade all forms of DNA and RNA while leaving proteins intact, making it crucial for applications requiring the removal of nucleic acids from complex biological samples in biopharmaceutical production.

We have collected answers to the most frequently asked questions for you.
Please select below or just scroll down to find detailed information about EndoCleave:

Where does EndoCleave originate and how does it work?
What are the benefits of using EndoCleave?
What are typical applications for EndoCleave?
What are the optimal conditions for using EndoCleave?
How can I detect potential residual EndoCleave during my process?
How does Roche ensure that EndoCleave meets high-quality standards?
What supporting documents are available for regulatory needs?
How is EndoCleave supplied?
Can I request a sample for testing?

Where does EndoCleave originate and how does it work?

EndoCleave is derived from Serratia marcescens, a wild-type endonuclease. It is expressed in a proprietary Roche Escherichia coli strain, allowing for antibiotics-free production to support high purity and safety standards.

EndoCleave works by cleaving the phosphodiester bonds in nucleic acids, effectively breaking them down into smaller oligonucleotides or mononucleotides. This process ensures comprehensive removal of contaminating nucleic acids, facilitating clearer and more accurate downstream analysis.

What are the benefits of using EndoCleave?

Broad-spectrum activity: Capable of degrading both single-stranded and double-stranded DNA and RNA.
Efficient nucleic acid removal: Eliminates nucleic acids to prevent interference with downstream processes.
Specificity: Targets nucleic acids without affecting proteins or other biomolecules¹.

Ease of Integration: Designed to be easily integrated into existing biopharmaceutical production processes.
Reliable partner: Known for high-quality raw materials, backed by Roche's reputation for excellence in biopharmaceutical manufacturing.
Regulatory support: Provides off-the-shelf supporting documents for your regulatory needs.

What are typical applications for EndoCleave?

EndoCleave is used in multiple applications within biopharmaceutical production such as:

Viral vector production: Essential for producing high-quality viral vectors like AAV by eliminating unwanted nucleic acids.
Viral vaccine production: Essential for producing high-quality viral vaccines like Influenza by eliminating unwanted nucleic acids.
Protein purification: Efficiently removes nucleic acids to purify protein samples.
Virus research: Ensures clear detection and analysis by eliminating host nucleic acids.
Bioprocessing: Reduces nucleic acid contamination in recombinant protein production and other biopharmaceutical processes.

What are the optimal conditions for using EndoCleave?

EndoCleave is versatile and effective across a broad range of conditions:

Temperature: Active between 20°C to 45°C.
pH range: Effective between pH 6.0 and 9.5, with optimal activity around pH 7.5 to 8.5.
Magnesium dependency: Requires the presence of divalent cations (Mg2+) for activity.

How can I detect potential residual EndoCleave during my process?

EndoCleave can be detected with commercially available residual kits based on ELISA tests designed for the detection of wt endonuclease from S.marcescens.

How does Roche ensure that EndoCleave meets high-quality standards?

Roche's Penzberg site in Germany is integral to our commitment to quality and reliability. EndoCleave is produced according to GMP Grade standards.

ISO 13485 certified: The site operates under an ISO 13485-certified Quality Management System, ensuring high standards in production and supply.
GMP Grade: Meets Good Manufacturing Practice standards beyond simple marketing terms for high reliability, aligning with biopharmaceutical manufacturing requirements.
Animal Origin-Free (AOF): Ensures the absence of animal-derived materials to avoid risks such as TSE/BSE.

Validated manufacturing and cleaning processes: Ensures the high quality and validation standards are met.
Extended impurity testing: Includes testing for endotoxins, bioburden, host-cell DNA, host-cell protein, and relevant heavy metals to reduce the risk of inflammation, genetic integration, immunogenicity, and toxicity.
Qualified personnel and facilities: All activities impacting product quality are performed by trained personnel in suitable facilities.
Traceability and controlled production: Raw materials are traceable, and production processes are controlled to maintain consistent quality.
Designed for biopharma needs: Endocleave specifications are designed in alignment with Roche's internal pharma requirements for viral vector manufacturing processes, ensuring it is well-suited to meet the stringent needs of Biopharma companies and CDMOs.
Compliance with regulatory guidelines: Endocleave helps achieve compliance with the FDA regulatory guidelines for residual host cell DNA, which is critical for ensuring product safety and regulatory compliance in biopharmaceutical manufacturing.

What supporting documents are available for regulatory needs?

Roche provides a comprehensive set of off-the-shelf supporting documents to facilitate regulatory submissions and compliance, including:

Certificate of Origin (COO)/ Certificate of Analysis (CoA)
GMP Grade statement/ Viral safety statement
Animal-Origin-Free statement/ antibiotics statement
Allergens and additives statement
more upon request

How is EndoCleave supplied?

EndoCleave is available in three convenient pack sizes tailored to suit various customer needs, from early development stages to commercial-scale production:

100 kU: Ideal for early development and small-scale research.
500 kU: Suitable for mid-scale production and process optimization.
5000 kU: Perfect for large-scale manufacturing and commercial applications.

Can I request a sample for testing?

Yes, Roche CustomBiotech offers samples of EndoCleave for preliminary testing in your specific applications.

Please contact our sales team to request a sample or for further information on how EndoCleave can enhance your workflow.

Request a sample

EndoCleave in a nutshell

EndoCleave, rec., GMP Grade is a reliable, high-performance endonuclease designed to efficiently and selectively degrade nucleic acids. Its utility in viral vector production, protein purification, and other bioprocessing applications makes it an essential component for biopharmaceutical workflows.

With GMP Grade quality, stringent quality controls, and various pack sizes to accommodate different scales of use, EndoCleave is made for biopharmaceutical manufacturing processes, enabling safety and efficacy.

Roche's commitment to quality, backed by our state-of-the-art manufacturing site in Penzberg, long-term enzyme production experience at high scales, and a dependable supply chain, makes us a reliable partner for biopharma companies and CDMOs.

Unlock unparalleled value at attractive rates - reach out to your regional Roche CustomBiotech team.

References:
1) Data on file at Roche
2) Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs), Guidance for Industry, January 2020