Provise™ Clearance Services
We understand the importance of your viral clearance study, which is why we are committed to providing a flexible and high quality service. While we handle all the work, you get full transparency, control, and insight into every aspect of the study.
Your Viral Clearance Partner
Our Provise™ Clearance Service deploys a team of highly trained & experienced process scientists and study directors on your behalf, to perform all your required process steps at our state-of-the-art facilities. We will communicate with you to inform you at every step without the need to leave your workplace, maximizing your team’s productivity. You will receive a QA-audited final report to expertly support your regulatory filing.
Our dedicated team leverages extensive experience in:
- Virus reduction filtration
- Column chromatography
- Column re-use studies
- Ethanol fractionation
- Viral inactivation by treatment with solvent/detergent and extreme pH
Working together to deliver your viral clearance study
Your dedicated process team will perform all viral clearance steps on your behalf, keeping you up to date with progress of your study. You will receive a final report and support through your regulatory journey, all while you are doing value-added work within your own facility.
Executing your study
- Executing your study
- Finalize technical documents
- Technical transfers
- Complete pre-study activity i.e., Cytotoxicity & Spike recovery
- Complete main study i.e., Chromatography & VRF (Virus Reduction Filtration)
Finalizing your study
- Finalizing your study
- Process & log reduction data compiled
- Peer & Quality review
- Delivery of final report
- Feedback survey
Related Resources
- Application Note: Designing Successful Viral Clearance Studies
In this paper, we will share how to ensure your manufacturing process has the capacity to remove or inactivate enveloped and non-enveloped viruses.
- Flyer: BioReliance® Standard Viral Clearance Services
Learn how our experts, with decade of experience, help design and execute your clearance studies.
- Infographic: BioReliance® Viral Clearance Services
Discover key numbers on our experience with viral clearance studies.
- Flyer: Roadmap to Success — Provise™ Clearance Services
Discover how we can do your viral clearance studies for you, keeping you informed along the way.
- Application Note: Viral Clearance Considerations for AAV Viral Vectors
Read about key factors to consider for virus inactivation steps or model virus panels for your AAV clearance study.
- Webinar: How Will ICH Q5A(R2) Affect the Design of Virus Clearance Studies?
In this webinar, you will learn about key updates in the ICH Q5A (R2) and how these may impact virus clearance study design.
- Webinar: Evaluating Viral Clearance for Continuous Processes
Learn about important viral clearance study considerations when transitioning to continuous processing.
- Webinar: Viral Safety for Novel Biological Therapies
In this webinar, you will learn strategies for ensuring the viral safety of novel therapies.
- Webinar: Viral Clearance — Something Went Wrong, What Do I Do Now?
In this webinar, we discuss potential issues that can arise during viral clearance study design and execution, and strategies to mitigate risks.
To continue reading please sign in or create an account.
Don't Have An Account?