AccScience Publishing / EJMO / Online First / DOI: 10.36922/EJMO025350359
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ORIGINAL RESEARCH ARTICLE

Comparative analysis of quality control data for adenovirus serotype 5- and 26-based viral vector vaccine across manufacturing sites

Daria Yu. Kolomiytseva1* ,  Anastasia A. Sirotkina1 ,  Natalia A. Litvinova1
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1 Department of Molecular Diagnostics, Cell Testing Laboratory, Generium, Petushinsky District, Vladimir Region, Russia
EJMO, 025350359 https://doi.org/10.36922/EJMO025350359
Received: 25 August 2025 | Revised: 21 November 2025 | Accepted: 30 December 2025 | Published online: 25 May 2026
© 2026 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution -Noncommercial 4.0 International License (CC-by the license) ( https://creativecommons.org/licenses/by-nc/4.0/ )
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Abstract

Introduction: The release of pharmaceutical products, including biotechnological viral vector vaccines based on adenovirus serotypes 5 and 26, requires analytical control using suitable methods for both intermediate products and the final drug formulation.

Objective: To demonstrate the stability of the vector vaccine production process against quality criteria using analytical methods and to prove the convergence of data obtained across multiple manufacturing sites.

Methods: Test samples consisted of vaccine batches from three manufacturing sites. Vaccine titer was determined via the 50% cell culture infectious dose method. Authenticity was assessed using an enzyme-linked immunosorbent assay-based biological test. Biosafety was confirmed using the plaque-forming unit assay.

Results: Eighteen samples from three manufacturing sites (six from each) were analyzed in accordance with the specification parameters. The analysis included determination of protein and DNA authenticity, capsid fullness, biosafety, and infectious titer. The authenticity of the DNA insert was also confirmed. The analyzed vaccine batches met the requirements for the content of replication-competent viral particles, proving their biosafety. The average infectious titer of the vaccine ranged from 0.92 × 107 to 4.06 × 107 vp/mL, which complies with the specification.

Conclusion: All tested samples met the established acceptance criteria. The comparability of quality control results across manufacturing sites indicates the reproducibility of the vaccine production process, a key indicator of the stability and reliability of the manufacturing technology.

Keywords: Vaccine preparation; Analytical methods; Quality control; Adenovirus; Coronavirus infection; Data convergence; Authenticity; Biosafety

Keywords
Vaccine preparation
Analytical methods
Quality control
Adenovirus
Coronavirus infection
Data convergence
Authenticity
Biosafety
Funding
None.
Conflict of interest
The authors are employees of JSC Generium, the manufacturer of the vaccine evaluated in this study. This affiliation is disclosed as a potential conflict of interest. The authors declare that their employment did not influence the study design, data collection, analysis, interpretation of results, or the decision to publish the findings.
References
  1. Ju JH, Lee N, Kim SH, et al. Points to consider for COVID- 19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform. Osong Public Health Res Perspect. 2022;13(1):4-14. doi: 10.24171/j.phrp.2021.0311
  2. Kis Z, Tak K, Ibrahim D, et al. Pandemic-response adenoviral vector and RNA vaccine manufacturing. NPJ Vaccines. 2022;7(1):29. doi: 10.1038/s41541-022-00447-3
  3. Chavda VP, Mehta AA, Zafar H, et al. Adenovirus-Based Single-Dose Vaccines for SARS-CoV-2: A Review. Front Biosci. 2025;30(7):25094. doi: 10.31083/FBL25094
  4. Joe CCD, Chopra N, Nestola P, Niemann J, Douglas AD. Rapid-response manufacturing of adenovirus-vectored vaccines. Nat Biotechnol. 2023;41(3):314-316. doi: 10.1038/s41587-023-01682-2
  5. Mela A, Rdzanek E, Poniatowski ŁA, et al. Epidemiological features and changes in the occurrence of infectious diseases in Poland from 2015 to 2020 in the context of the emerging novel SARS-CoV-2 (COVID-19) pandemic. Oncol Clin Pract. 2022;18(4):247–256. doi: 10.5603/OCP.2022.0022
  6. Hong L, Li J, Zeng W, et al. The seroprevalence of adenoviruses since 20001. Emerg Microbes Infect. 2025;14(1):2475831. doi: 10.1080/22221751.2025.2475831
  7. Wang S, Liang B, Wang W, et al. Viral vectored vaccines: design, development, preventive and therapeutic applications in human diseases. Signal Transduct Target Ther. 2023;8(1):149. doi: 10.1038/s41392-023-01408-5
  8. Zasada AA, Darlińska A, Wiatrzyk A, et al. COVID-19 Vaccines over Three Years after the Outbreak of the COVID- 19 Epidemic. Viruses. 2023;15(9):1786. doi: 10.3390/v15091786
  9. Elkashif A, Alhashimi M, Sayedahmed EE, Sambhara S, Mittal SK. Adenoviral vector-based platforms for developing effective vaccines to combat respiratory viral infections. Clin Transl Immunol. 2021;10(10):e1345. doi: 10.1002/cti2.1345
  10. Hackett NR, Crystal RG. Four decades of adenovirus gene transfer vectors: History and current use. Mol Ther. 2025;33(5):2192-2204. doi: 10.1016/j.ymthe.2025.03.062
  11. Srivastava A, Mallela KMG, Deorkar N, Brophy G. Manufacturing Challenges and Rational Formulation Development for AAV Viral Vectors. J Pharm Sci. 2021;110(7):2609-2624. doi: 10.1016/j.xphs.2021.03.024
  12. European Medicines Agency (EMA). Guideline on Quality, Non-clinical and Clinical Aspects of Gene Therapy Medicinal Products. EMA; 2018.
  13. International Council for Harmonisation. ICH Q5A(R2): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. ICH; 2023.
  14. International Council for Harmonisation. ICH Q14: Analytical Procedure Development. ICH; 2023.
  15. Wang X, Hetzel M, Zhang W, Ehrhardt A, Bayer W. Comparative analysis of the impact of 40 adenovirus types on dendritic cell activation and CD8+ T cell proliferation capacity for the identification of favorable immunization vector candidates. Front Immunol. 2023;14:1286622. doi: 10.3389/fimmu.2023.1286622
  16. Shayakhmetov DM, Lieber A. Dependence of Adenovirus Infectivity on Length of the Fiber Shaft Domain. J Virol. 2000;74(22):10274-10286. doi: 10.1128/jvi.74.22.10274-10286.2000
  17. US Food and Drug Administration (FDA). Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products: Draft Guidance for Industry. FDA; 2023.
  18. Vellinga J, Smith JP, Lipiec A, et al. Challenges in manufacturing adenoviral vectors for global vaccine product deployment. Hum Gene Ther. 2014;25(4):318-327. doi: 10.1089/hum.2014.007
  19. Silva AC, Peixoto C, Lucas T, Küppers C, Cruz PE, Alves PM, Kochanek S. Adenovirus vector production and purification. Curr Gene Ther. 2010;10(6):437-455. doi: 10.2174/156652310793797694
  20. Afkhami S, Yao Y, Xing Z. Methods and clinical development of adenovirus-vectored vaccines against mucosal pathogens. Mol Methods Clin Dev. 2016;3:16030. doi: 10.1038/mtm.2016.30
  21. Tanaka Y, Hamano S, Ishii-Watabe A, Saito Y, Kikura- Hanajiri R. Method validation and assessment of the biodistribution and shedding for adenovirus vector-based vaccine using qPCR and dPCR. Mol Ther Methods Clin Dev. 2025;33(3):101549. doi: 10.1016/j.omtm.2025.101549
  22. Mostafa MM, AbdelAllah NH, Elzanfaly ES, Sedik GA. 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 Pharm Sci Tech. 2025;26(7). doi: 10.1208/s12249-025-03220-6
  23. Peixoto C, Ferreira TB, Sousa MF, Carrondo MJ, Alves PM. Towards purification of adenoviral vectors based on membrane technology. Biotechnol Prog. 2008;24(6):1290- 1296. doi: 10.1002/btpr.25
  24. Parish LA, Rele S, Hofmeyer KA, Luck BB, Wolfe DN. Strategic and Technical Considerations in Manufacturing Viral Vector Vaccines for the Biomedical Advanced Research and Development Authority Threats. Vaccines. 2025; 13(1):73. doi: 10.3390/vaccines13010073
  25. Cockroft A, Wilson A. Comparability: What We Can Learn from the Review of Advanced Therapy Medicinal Products. Regen Med. 2021;16(7):655-667. doi: 10.2217/rme-2021-0026
  26. Lubiniecki A, Volkin DB, Federici M, et al. Comparability assessments of process and product changes made during development of two different monoclonal antibodies. Biologicals. 2011;39(1):9-22. doi: 10.1016/j.biologicals.2010.08.004
  27. Ferreira RG, Gordon NF, Stock R, Petrides D. Adenoviral Vector COVID-19 Vaccines: Process and Cost Analysis. Processes. 2021; 9(8):1430. doi: 10.3390/pr9081430
  28. Dold C, Marsay L, Wang N, et al. An adenoviral-vectored vaccine confers seroprotection against capsular group B meningococcal disease. Sci Transl Med. 2023;15(701): eade3901. doi: 10.1126/scitranslmed.ade3901
  29. Wang JH, Gessler DJ, Zhan W, Gallagher TL, Gao G. Adeno-associated virus as a delivery vector for gene therapy of human diseases. Sig Transduct Target Ther. 2024;9(1). doi: 10.1038/s41392-024-01780-w
  30. US Food and Drug Administration (FDA). Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry. FDA; 2020. Available from: https:// www.fda.gov/regulatory-information/search-fda-guidance-documents/chemistry-manufacturing-and-control-cmc-information-human-gene-therapy-investigational-new-drug [Last accessed on June 14,2024].
  31. Iranmanesh M, Zailani S, Hyun SS, Ali MH, Kim K. Impact of Lean Manufacturing Practices on Firms’ Sustainable Performance: Lean Culture as a Moderator. Sustainability. 2019;11(4):1112. doi: 10.3390/su11041112
  32. Kolomiytseva DY, Litvinova NA, Shukurov RR. Detection of Replication-Competent Adenoviral Particles in the Vector Vaccines Salnavac® and Gam-Covid-Vac® against the New Coronavirus Infection Covid-19. Biochem Moscow Suppl Ser B. 2025;19(1):89-97. doi: 10.1134/s1990750824600717
  33. Boucher P, Cui X, Curiel DT. Adenoviral vectors for in vivo delivery of CRISPR-Cas gene editors. J Control Release. 2020;327:788-800. doi: 10.1016/j.jconrel.2020.09.003
  34. Marks J. A Review of Virus-Vectored Vaccines: Current Production Methods, Uses, Issues, and Future Perspectives. Master’s research project. Department of Biology and Microbiology, South Dakota State University; 2022.
  35. Wang J, Cui J, Li G, Yu L. Research advances in replication-deficient viral vector vaccines. Front Vet Sci. 2025;12. doi: 10.3389/fvets.2025.1535328
  36. International Council for Harmonisation. ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. ICH; 2004.
  37. Tang J, Amin MA, Campian JL. Past, Present, and Future of Viral Vector Vaccine Platforms: A Comprehensive Review. Vaccines. 2025;13(5):524. doi: 10.3390/vaccines13050524
  38. Travieso T, Li J, Mahesh S, Mello JDFRE, Blasi M. The use of viral vectors in vaccine development. NPJ Vaccines. 2022;7(1):75. doi: 10.1038/s41541-022-00503-y
  39. Kajon AE. Adenovirus infections: new insights for the clinical laboratory. J Clin Microbiol. 2024;62(9):e0083622. doi: 10.1128/jcm.00836-22
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Eurasian Journal of Medicine and Oncology, Electronic ISSN: 2587-196X Print ISSN: 2587-2400, Published by AccScience Publishing
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