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Given this potential risk, an assessment of the virus removal\/inactivation that can be achieved by a product's established purification process is required per ICH Q5A guidelines. This viral safety assessment is a critical component of filing an investigational new drug (IND) application for an early\u2010stage product. A viral clearance study must evaluate purification steps in a manufacturing process that are effective in inactivating\/removing viruses. The traditional approach to viral clearance studies includes spiking in one virus at a time and quantifying the level of reduction of individual virus by a validated assay for that virus. This paper discusses an approach to spiking in multiple viruses in the same load and quantifying clearance in virus\u2010specific assays to help accelerate the timeline to IND filing for an early\u2010stage product while also reducing support and material requirements for executing viral clearance studies.<\/jats:p>","DOI":"10.1002\/bit.70085","type":"journal-article","created":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T16:46:36Z","timestamp":1761497196000},"page":"186-195","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Application of Dual Virus Spike Approach to Accelerate Early\u2010Stage Viral Clearance Studies"],"prefix":"10.1002","volume":"123","author":[{"given":"Heather Bethea","family":"Horne","sequence":"first","affiliation":[{"name":"KBI Biopharma, Process Development Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-5811-0368","authenticated-orcid":false,"given":"Thomas B.","family":"Lindsey","sequence":"additional","affiliation":[{"name":"KBI Biopharma, Process Development Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leslie S.","family":"Wolfe","sequence":"additional","affiliation":[{"name":"KBI Biopharma, Process Development Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Symya","family":"Chumbris","sequence":"additional","affiliation":[{"name":"Texcell North America, Viral Clearance Services Frederick Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Dickson","sequence":"additional","affiliation":[{"name":"Texcell North America, Viral Clearance Services Frederick Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akunna","family":"Iheanacho","sequence":"additional","affiliation":[{"name":"Texcell North America, Viral Clearance Services Frederick Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,10,26]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41587\u2010020\u20100507\u20102"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/btpr.2183"},{"key":"e_1_2_8_4_1","unstructured":"Committee for Proprietary Medicinal Products European Agency for the Evaluation of Medicinal Products.1996.Note for Guidance on Virus Validation Studies: The Design Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses. 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