ArticleBiologicals : journal of the International Association of Biological Standardization2010
Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine.
Article in Biologicals : journal of the International Association of Biological Standardization, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
28 citing papers in PubMed, 58 citations in OpenAlex.
- Trial
- Techno-economic evaluation of Islamic-compliant cell-based influenza vaccine production using AGE1.CR cell line in comparison to the current production using MDCK cell line.Bioprocess and biosystems engineering · 2026Article
- Screening of Low-Tumorigenic MDCK Cells for Potential Influenza Vaccine Substrates and Transcriptomic Analyses.International journal of molecular sciences · 2026Article
- mRNA-based seasonal influenza vaccines: an overview of immunogenicity, efficacy, and safety.Frontiers in immunology · 2026Review
- Innovations in cell culture-based influenza vaccine manufacturing - from static cultures to high cell density cultivations.Human vaccines & immunotherapeutics · 2024Review
- A synthetic TLR4 agonist significantly increases humoral immune responses and the protective ability of an MDCK-cell-derived inactivated H7N9 vaccine in mice.Archives of virology · 2024Article
- From single-cell cloning to high-yield influenza virus production - implementing advanced technologies in vaccine process development.Engineering in life sciences · 2024Article
- Article
- Article
- [Health Technology Assessment: a value-based tool for the evaluation of healthcare technologies. Reassessment of the cell-culture-derived quadrivalent influenza vaccine: Flucelvax TetraJournal of preventive medicine and hygiene · 2022Article
- Article
- Identification and differential expression of microRNAs in Madin-Darby canine kidney cells with high and low tumorigenicities.Genes & genomics · 2022Article
- Influenza vaccines: Past, present, and future.Reviews in medical virology · 2022Review
- Enhanced isolation of influenza viruses in qualified cells improves the probability of well-matched vaccines.NPJ vaccines · 2021Article
- Frontiers in the Standardization of the Plant Platform for High Scale Production of Vaccines.Plants (Basel, Switzerland) · 2021Review
- Tracking changes in adaptation to suspension growth for MDCK cells: cell growth correlates with levels of metabolites, enzymes and proteins.Applied microbiology and biotechnology · 2021Article
- Review
- Cell culture-derived influenza vaccines in the severe 2017-2018 epidemic season: a step towards improved influenza vaccine effectiveness.NPJ vaccines · 2018Review
- The hUC-MSCs cell line CCRC-1 represents a novel, safe and high-yielding HDCs for the production of human viral vaccines.Scientific reports · 2017Article
- Egg-Independent Influenza Vaccines and Vaccine Candidates.Vaccines · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
Abstract
Cell culture-based production methods may assist in meeting increasing demand for seasonal influenza vaccines and developing production flexibility required for addressing influenza pandemics. MDCK-33016PF cells are used in propagation of a cell-based seasonal influenza vaccine (Optaflu); but, like most continuous cell lines, can grow in immunocompromised mice to produce tumors. It is, therefore, essential that no residual cells remain within the vaccine, that cell lysates or DNA are not oncogenic, and that the cell substrate does not contain oncogenic viruses or oncogenic DNA. Multiple, redundant processes ensure the safety of influenza vaccines produced in MDCK-33016PF cells. The probability of a residual cell being present in a dose of vaccine is approximately 1 in 10(34). Residual MDCK-DNA is < or =10 ng per dose and the ss-propiolactone used to inactivate influenza virus results in reduction of detectable DNA to less than 200 base pairs (bp). Degenerate PCR and specific PCR confirm exclusion of oncogenic viruses. The manufacturing process has been validated for its capacity to remove and inactivate viruses. We conclude that the theoretical risks arising from manufacturing seasonal influenza vaccine using MDCK-33016PF cells are reduced to levels that are effectively zero by the multiple, orthogonal processes used during production.
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What OpenQuestion holds
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.