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

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

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