Viral Clearance Validation
Greater Log Reduction Values in Fewer Steps
Viral clearance is a critical component of regulatory submissions as it helps demonstrate the overall product safety of your biopharmaceutical. Through thousands of studies, we have developed a service platform that supports regulatory success.
Our Differentiators
- Developed service platform optimized for peak performance across multiple runs and products
- Created a more effective method for achieving higher log reduction values in less steps compared to the “percent spike model”
- Ensures regulatory success by leveraging intelligent study design, database, platform, and decades of experience
- On-premise, remote, or continuous chromatography study capabilities
- Flexibility – Expertise to work with equipment from multiple vendors
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Viral Clearance Validation Platform Overview
- Database with over 20,000 entries used for study design
- Large-Volume Testing and Sensitive Plaque Assays
- High-Titer Virus Stocks
- Ultra-Purified Preparations of Virus Spikes
- Consistent data by enhancing Viral Removal Filtration
- Virus spiking strategy based on total viral load compared to percent spike delivers better results
Study Categories and Process Experience
Viral Clearance Database
Supported Products
- Recombinant proteins
- Monoclonal antibodies
- Tissue and plasma products
- Gene therapy vectors
- Vaccines
- Raw materials
- Devices
Features
- More than 3500 different viral clearance or inactivation studies
- Information tabulated from 20,000 data points and continuously expanding
- Log reduction values obtained over a 25-year span
- Extensive library of inactivation and removal process steps
Multiple Search Criteria
- Process step (AEX chromatography, solvent/detergent, nano¬ltration)
- Virus used (over 30 di erent types)
- Process step parameters (pH, flow rate, conductivity)
- Protein and viral load
- Infectivity or PCR detection methodology
- General scale-down parameters for individual processes
Large Volume Virus Detection Methods – Viral Plaque Assay vs TCID50
The viral plaque assay is a true quantitative method, as it counts single infectious units. In contrast, TCID50 scores based on a percentage of cell death, with wells scored as positive or negative for viral infection. When a process step completely removes or inactivates virus (i.e. no virus detected), we’re able to increase plaque assay sensitivity and Log10 Reduction Value (LRV) for our client simply by plating and testing more sample volume.
High Titer, Ultra Purified Virus Stocks
With our meticulously developed and highly-refined approaches to purification techniques, we have three classifications of virus for use in studies:
- Ultra 1 (standard)
- Ultra 2 (highly purified Reovirus, PrV and MuLVs)
- Ultra 3 (highly puried PPV and MVM)
Total Viral Load Challenge Spiking Strategy
By focusing on the Viral Removal Filtration step, we pioneered a new approach, the Total Viral Load Challenge which scientifically showcases a repeatable method for robust viral clearance that has been accepted by global regulatory bodies.
View data published on BPI that demonstrates our superior approach
Read an interview that recaps our R&D efforts that led to the service platform creation
Viral Clearance Studies Without Rejection From Regulatory Authorities

TEM as a Viral Clearance Study Tool
When applied to viral clearance studies, Transmission Electron Microscopy can help detect otherwise unsuspected viral particles. TEM visualizes physical virus features to expose viral particles. It complements and extends biological methods like ELISA, PCR that identify specific virus types.
Virus Titers
Request sample virus COAs
Viral Clearance Validation Strategies for Continuous Chromatography


Continuous Processing Proof of Concept
By partnering with BMS, we collaborated on a study to prove the possibility of decoupling a Continuous Chromatography model for Viral Clearance Validation. Not only effective, the approach provides a framework for demonstrating regulatory compliance.
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