ArticleGene therapy2001
Development of formulations that enhance physical stability of viral vectors for gene therapy.
Article in Gene therapy, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 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
69 citing papers in PubMed.
- Developmental Progress and Future Potential for Inhaled Biologics in the Treatment of Respiratory Diseases.Drugs · 2026Review
- Ensuring vaccine cold chain integrity: A rapid and low-cost test for identifying heat-exposed sucrose-containing vaccines.International journal of pharmaceutics: X · 2026Article
- Stability of the two enveloped viruses NDV LaSota and YF-ZIKprM/E to support process development.PloS one · 2026Article
- Lyophilization of Adeno-Associated Virus Serotypes for Storage and Global Distribution.Biomedicines · 2025Article
- Integrated Analytical Techniques to Investigate the Effect of the Freezing/Thawing Cycles on the Non-replicating Recombinant Chimpanzee Adenovirus Viral Vector COVID-19 Vaccine.AAPS PharmSciTech · 2025Article
- Enhanced Discriminability of Viral Vectors in Viscous Nanopores.Small methods · 2025Article
- Article
- Formulation development and feasibility of AAV5 as a lyophilized drug product.Journal of pharmaceutical sciences · 2025Article
- Advancing AAV vector manufacturing: challenges, innovations, and future directions for gene therapy.Frontiers in molecular medicine · 2025Review
- Development of an optimized SEC method for characterization of genome DNA leakage from adeno-associated virus products.Analytical and bioanalytical chemistry · 2024Article
- Crucial aspects for maintaining rAAV stability.Scientific reports · 2024Article
- Evaluation of a rapid multi-attribute combinatorial high-throughput UV-Vis/DLS/SLS analytical platform for rAAV quantification and characterization.Molecular therapy. Methods & clinical development · 2024Article
- A comprehensive comparison of DNA and RNA vaccines.Advanced drug delivery reviews · 2024Review
- Development of Robust Freeze-Drying Process for Long-Term Stability of rVSV-SARS-CoV-2 Vaccine.Viruses · 2024Article
- DNA Released by Adeno-Associated Virus Strongly Alters Capsid Aggregation Kinetics in a Physiological Solution.Biomacromolecules · 2024Article
- Analysis of the impact of pluronic acid on the thermal stability and infectivity of AAV6.2FF.BMC biotechnology · 2024Article
- Production of recombinant vesicular stomatitis virus-based vectors by tangential flow depth filtration.Applied microbiology and biotechnology · 2024Article
- Study of Oncolytic Virus Preservation and Formulation.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Lyophilization to enable distribution of ChAdOx1 and ChAdOx2 adenovirus-vectored vaccines without refrigeration.NPJ vaccines · 2023Article
- Single-shot AAV-vectored vaccine against SARS-CoV-2 with fast and long-lasting immunity.Acta pharmaceutica Sinica. B · 2023Article
9 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
This study summarizes our initial efforts to address an issue that is critical to the success of any multicenter gene therapy clinical trial - maintenance of vector viability during shipping and storage at remote test sites. We have identified formulation and processing factors that influence stability of viral preparations such as selection of appropriate buffer systems, cryoprotectants, and storage conditions. Adenovirus and adeno-associated virus expressing E. coli beta-galactosidase (lacZ) were suspended in blends of complex carbohydrates, cyclodextrins and various surfactants. X-gal stains of 293 and 84-31 cells were used to determine infectious titer of all preparations. Potassium phosphate-buffered preparations consistently maintained high viral titers after storage at -20 and 4 degrees C. Blends of sucrose, mannitol, and surfactant showed negligible loss of titer for 35 days at 4 degrees C. Formulations of sucrose and cyclodextrin were stable for 2 years at -20 degrees C. Negligible loss in titer was observed in unit-dose viral preparations lyophilized in sucrose and stored at 4 degrees C for 1 year after an initial loss of 0.5 log due to processing. Studies with lyophilized sucrose/mannitol blends have shown that viral recovery after processing is directly related to the final moisture content of the dried product. Virus concentration also plays a significant role in recovery after processing with highly concentrated preparations showing minimal loss in titer after lyophilization. In summary, lyophilized preparations that can be shipped and stored at 25 degrees C offer a solution to the current problem of distribution of viral vectors for clinical trials.
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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.