Viral clearance for biopharmaceutical downstream processes
Open accessAbstract
Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses. This paper reviews regulatory guidance and practical strategies for designing viral clearance studies. Essential elements of a developmental phase-appropriate viral clearance package are detailed. These include scale-down model qualification, virus spike experiments and validation (clearance evaluation) of manufacturing process steps. Heuristics and learnings from available data are shared. Developments in this area including generic validation strategies, multiviral spiking strategies and use of newer model viruses for nonconventional substrates are also described. This review provides a framework for a comprehensive viral validation package for regulatory submissions.
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For recombinant viruses, master virus banks (MVBs) are generated and thoroughly characterized for contamination by adventitious viruses.
“For recombinant viruses, master virus banks (MVBs) are generated and thoroughly characterized for contamination by adventitious viruses 52 .”
From Viral contamination in biologic manufacture and implications for emerging therapies (2020) · cites this paper as [52]
The risk-assessment discussion (p. 128) says master and working cell banks are extensively tested for viral contamination. It does not say that master virus banks are generated or characterized for recombinant viruses; cell banks and virus banks are distinct. (LLM, conf=0.78)
Experimental — accuracy not yet measured
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Self-citation
- Authors
- Shukla, A. A., & Aranha, H.
- ORCID
- Shukla, Abhinav A
- Venue
- Pharmaceutical Bioprocessing
- Publisher
- OMICS Publishing Group
- Published
- 2015-04
- Volume
- 3
- Issue
- 2
- Pages
- 127-138
- ISSN
- 2048-9145 (ISSN-L)
- 2048-9153
- OpenAlex
- W2001310472
- Cited by
- 63
- References
- 60
- Citations by year
- 2026: 7 · 2025: 7 · 2024: 7 · 2023: 4 · 2022: 6 · 2021: 4 · 2020: 10 · 2019: 6 · 2018: 5 · 2017: 5 · 2016: 2
- FWCI
- 1.74
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Licence
- cc-by
- Locations
- Pharmaceutical Bioprocessing (publishedVersion)
- Zenodo (CERN European Organization for Nuclear Research) (cc-by)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Viral Infectious Diseases and Gene Expression in Insects
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Keywords
- viral clearance, biopharmaceuticals, downstream processing, manufacturing process validation, regulatory guidelines
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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