Viral Clearance Testing

Planning Your Viral Clearance Study

We understand the criticality of viral clearance in your product development which is why we offer viral clearance across all 3 of our sites. Our global presence allows for local language communication and timely updates on your studies, providing flexibility to ensure you get your desired slot. Across our sites, we offer three different regulatory-accepted service packages:

• Standard Clearance – Book time in our facility to work with our expert team to execute your study
• Provise^® Clearance – Let our team handle your study while you do value-added work at your own facility, we keep you informed along the way
• Hybrid Clearance – You perform the steps that you need to and leave the rest to us

Executing Your Viral Clearance Study

Our team of highly skilled process scientists, scientists, and downstream scientists are on-site to support you or execute the study on your behalf. We have proven understanding of the requirements and individual steps to effectively complete IND and BLA studies including:

• Low/High pH
• Virus reduction filtration
• Cation chromatography exchange
• Anion chromatography exchange
• Protein affinity chromatography
• Pasteurization and many more!

Dual Spiking for Viral Clearance

Our dual spiking service offering enhances efficiency of viral clearance studies by employing a multi-spike strategy with Murine Leukaemia Virus (MLV) and Murine Minute Virus (MMV), significantly reducing study timelines and sampling burdens.

Why choose a dual spiked approach?

1. Efficiency Gains: Our dual spiking method allows for simultaneous evaluation of both MLV and MMV, streamlining the purification process and reducing the in-lab time for viral clearance studies. This is crucial for meeting regulatory timelines and expediting clinical trial initiation.
2. Resource Optimization: With less product required for spiking runs, there is a greater yield of filled product available for clinical trials. Additionally, the dual spiking approach reduces documentation volume, leading to faster review and audit processes.
3. Cost Reduction: The service minimizes the volume of buffers, and the number of columns or membrane devices required, leading to lower operational costs and reduced waste disposal requirements.
4. Robust Validation & Quality Assurance: The dual spiking strategy has been rigorously validated at our Rockville facility to ensure assay robustness, maintaining high accuracy and precision in viral detection, thus supporting the integrity of the viral safety evaluation.

BioPure Virus Stocks used in Your Viral Clearance Study

We produce our virus internally to ensure high viral titres and low levels of potential contaminants, translating to outstanding performance for all downstream process studies. BioPure virus stocks are produced from fully characterized virus stocks and are used to evaluate the reduction of virus.

BioPure Gold virus stock is used for nanofiltration steps for additional sensitivity, as it’s been subjected to additional purification to produce the cleanest and most aggregate-free material. Our viral clearance experts can discuss & consult on the use of appropriate virus stocks for each of your studies.