Cutting Time, Cost, and Material for Viral Clearance Studies: A Proven Dual Virus Spike Approach

Summary 

KBI Biopharma and Texcell North America developed a proven dual virus spike approach for viral clearance studies, published in Biotechnology and Bioengineering (2025). The method tests XMuLV and MMV simultaneously, reducing study timeline by 50%, cost of goods by 28%, and material requirements by ~30% compared to traditional single-virus testing. 

 
Introduction 

Viral clearance studies are a critical requirement for biopharmaceutical manufacturing, but traditional single-virus testing is time-consuming and expensive. Biopharmaceutical products derived from cell lines carry a risk of viral infection. Given this risk, regulatory guidelines require an assessment of virus removal and inactivation capabilities of a product's established purification process. The viral safety assessment is a critical component of filing an investigational new drug (IND) application for early-stage products. 

Traditionally, viral clearance studies spike in one virus at a time and quantify the level of reduction of individual viruses by validated assays specific to each virus. To streamline viral clearance studies, researchers at KBI Biopharma collaborated with Texcell North America and developed an innovative dual virus spike approach that includes spiking two viruses simultaneously in the same load, processing over the unit operation being evaluated, and then quantifying clearance using virus-specific assays.

This key methodology, recently published in Biotechnology and Bioengineering (Horne et al., 2025, DOI: 10.1002/bit.70085), merges two study workflows into one, reducing timeline and material requirements tremendously for viral clearance studies. 

 
The Problem with Traditional Viral Clearance Testing  

When pharmaceutical companies develop biologic drugs (i.e. monoclonal antibodies), they must prove the manufacturing process will effectively remove viruses to protect patient safety. Traditional testing requires running separate experiments for each virus type. This process is expensive, time-consuming, and requires large amounts of precious product, especially in pre-IND development.
 

The Dual Virus Spike Solution 

Together with Texcell North America, researchers at KBI Biopharma’s facility evaluated a "dual virus spike" approach where they test two viruses simultaneously in the same experiment instead of separately. Both viruses (i.e. XMuLV and MMV) are spiked into the same load material at the same time and go through the purification process together. After purification, they use virus-specific bioassays to detect and quantify each virus separately. 

Dual Virus Spike Proven Results and Performance: 

• The dual-spike approach produced the same viral clearance results as traditional single-virus testing 

• The process worked effectively across multiple purification steps (i.e. Protein A chromatography, mixed mode anion exchange chromatography, cation exchange chromatography and virus filtration) 

• No negative interactions occurred when both viruses were present together 

Real-World Benefits: 

• 50% time saved for viral spiking study  

• 28% cost savings on equipment and materials 

• ~30% reduction in product requirements 

• Allows companies to start testing earlier in development, potentially catching issues before expensive large-scale manufacturing 

These improvements make dual virus spike testing particularly valuable for early-stage biotech companies working toward IND submission. 

Why Dual Spike Matters: 

This proven approach to viral safety testing reduces both the cost and timeline for CMC development. Companies can now conduct these critical safety studies using material from smaller pilot runs rather than waiting for full manufacturing batches, potentially taking viral clearance testing off the critical path to filing investigational new drug (IND) applications. 

The Bottom Line:

This proven approach reflects KBI Biopharma's science-driven approach to bring innovation based on customer needs. By developing a smarter testing method that cuts time, costs, and material requirements in half, we're removing barriers that slow drug development and helping biopharmaceutical drug developers get treatments for patients who need them. 

About the Authors: 

Heather Horne is an Associate Director of Downstream Process Development at KBI Biopharma's Venture Center in Durham, North Carolina. With a PhD in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill and over 14 years of experience at KBI, she specializes in developing innovative protein purification strategies for biotherapeutics.  She also has extensive experience with both early and late-stage viral clearance studies. 

Thomas Lindsey is a Process Development Scientist II based at KBI Biopharma's Venture Center in Durham, NC. He has been with KBI Biopharma for 8 years and brings over 11 years of experience in the biopharmaceutical industry, driving innovation and collaboration to advance cutting-edge therapies. 

Acknowledgement: 

This research was conducted with the unwavering support of Leslie S. Wolfe at KBI Biopharma. Special thanks to Symya Chumbris, Matthew Dickson, and Akunna Iheanacho at Texcell North America, who handled and demonstrated deep expertise in the assay development, virus stocks, spiking of the virus, and all the testing throughout this study. 

Ready to reduce your viral clearance study timeline and costs?  

Contact our downstream process development team to learn how KBI's dual virus spike approach will help reduce your time to IND filing while cutting costs and material requirements.  

Reference: 

Horne, H.B., Lindsey, T.B., Wolfe, L.S., Chumbris, S., Dickson, M., & Iheanacho, A. (2025). Application of Dual Virus Spike Approach to Accelerate Early-Stage Viral Clearance Studies. Biotechnology and Bioengineering. https://doi.org/10.1002/bit.70085