Development of shelf stable formulation for adenovirus vectored vaccines and therapeutics

Abstract

Abstract 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.