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<p>A major limitation of therapeutic delivery is the cold chain storage requirement. Adenoviruses (AdV) have been demonstrated to be an effective delivery vector for several indications including COVID-19 vaccines but are limited by storage and transportation conditions. Previous work has demonstrated formulation and drying of vectored vaccines with pullulan and trehalose-based (PT) films significantly improves thermostabilization. To increase the accessibility of AdV based therapeutics, we developed a vacuum based drying methodology with optimized PT excipients resulting in a shelf stable product. We demonstrate the thermostability of formulated and dried AdV at 55°C for 7 weeks with less than 0.5 total log IU loss, and over 44 weeks at 37°C with less than 0.25 total log IU loss. Additionally, murine vaccination with the ChAd-TriCoV/Mac vaccine showed no difference in response between fresh and aged at 37°C for 44 weeks. These data demonstrate our formulation methodology’s performance, resulting in a shelf stable formulation for AdV based therapeutics.</p>

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Development of shelf stable formulation for adenovirus vectored vaccines and therapeutics

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月30日

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  • Jeremy A. Iwashkiw,
  • Aaisha Ameen,
  • Natallia Kazhdan,
  • Sam Afkhami,
  • Michael R. D’Agostino,
  • Kyle Amaral,
  • Matthew S. Miller,
  • Jody E. Beecher,
  • Carlos D. M. Filipe,
  • Brian D. Lichty

摘要

A major limitation of therapeutic delivery is the cold chain storage requirement. Adenoviruses (AdV) have been demonstrated to be an effective delivery vector for several indications including COVID-19 vaccines but are limited by storage and transportation conditions. Previous work has demonstrated formulation and drying of vectored vaccines with pullulan and trehalose-based (PT) films significantly improves thermostabilization. To increase the accessibility of AdV based therapeutics, we developed a vacuum based drying methodology with optimized PT excipients resulting in a shelf stable product. We demonstrate the thermostability of formulated and dried AdV at 55°C for 7 weeks with less than 0.5 total log IU loss, and over 44 weeks at 37°C with less than 0.25 total log IU loss. Additionally, murine vaccination with the ChAd-TriCoV/Mac vaccine showed no difference in response between fresh and aged at 37°C for 44 weeks. These data demonstrate our formulation methodology’s performance, resulting in a shelf stable formulation for AdV based therapeutics.