ArticleBiotechnology and bioengineering2026
Application of Dual Virus Spike Approach to Accelerate Early-Stage Viral Clearance Studies.
Article in Biotechnology and bioengineering, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Application of Dual Virus Spike Approach to Accelerate Early-Stage Viral Clearance Studies.Biotechnology and bioengineering · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biotechnology products derived from cell lines carry a risk of viral infection. 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-stage 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-specific assays to help accelerate the timeline to IND filing for an early-stage product while also reducing support and material requirements for executing viral clearance studies.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.