Identification of Excipients for Stabilizing Fiberless Adenovirus as Biopharmaceuticals

Kupgan, Grit; Choudhari, Shyamal P.; Flynn, Nicholas; Nigatu, Adane S.; Vupputuri, Sravanthi; Picking, Wendy L.; Picking, William D.; Ramsey, Joshua D.

doi:10.1016/j.xphs.2017.04.013

Cited by 2 publications

(2 citation statements)

References 42 publications

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“…There have been a number of efforts to enhance stability of adenovirus-based vaccines in liquid formulations, achieving stability for several months at 2–8 °C or a number of weeks at 15–30 °C 19 – 21 . Other groups have reported improvement in stability by drying vaccines using lyophilisation 22 , 23 , spray drying 24 – 26 , and nano-patch technology 27 , in some cases demonstrating short-term stability (weeks) at temperatures up to 37 °C 20 .…”

Section: Introductionmentioning

confidence: 99%

Characterisation of factors contributing to the performance of nonwoven fibrous matrices as substrates for adenovirus vectored vaccine stabilisation

Dulal

Gharaei

Berg

et al. 2021

Sci Rep

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Adenovirus vectors offer a platform technology for vaccine development. The value of the platform has been proven during the COVID-19 pandemic. Although good stability at 2–8 °C is an advantage of the platform, non-cold-chain distribution would have substantial advantages, in particular in low-income countries. We have previously reported a novel, potentially less expensive thermostabilisation approach using a combination of simple sugars and glass micro-fibrous matrix, achieving excellent recovery of adenovirus-vectored vaccines after storage at temperatures as high as 45 °C. This matrix is, however, prone to fragmentation and so not suitable for clinical translation. Here, we report an investigation of alternative fibrous matrices which might be suitable for clinical use. A number of commercially-available matrices permitted good protein recovery, quality of sugar glass and moisture content of the dried product but did not achieve the thermostabilisation performance of the original glass fibre matrix. We therefore further investigated physical and chemical characteristics of the glass fibre matrix and its components, finding that the polyvinyl alcohol present in the glass fibre matrix assists vaccine stability. This finding enabled us to identify a potentially biocompatible matrix with encouraging performance. We discuss remaining challenges for transfer of the technology into clinical use, including reliability of process performance.

show abstract

Section: Introductionmentioning

confidence: 99%

Characterisation of factors contributing to the performance of nonwoven fibrous matrices as substrates for adenovirus vectored vaccine stabilisation

Dulal

Gharaei

Berg

et al. 2021

Sci Rep

View full text Add to dashboard Cite

show abstract

“…There have been a number of efforts to enhance stability of adenovirus-based vaccines in liquid formulation 17–19 . Other groups have reported improvement in stability by drying vaccines using lyophilisation 20, 21 , spray drying 22–24 , and nano-patch technology 25 .…”

Section: Introductionmentioning

confidence: 99%

Characterisation of factors contributing to the performance of nonwoven fibrous matrices as substrates for adenovirus vectored vaccine stabilisation

Dulal

Walters

Hawkins

et al. 2020

Preprint

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The global network of fridges and freezers known as the “cold chain” can account for a significant proportion of the total cost of vaccination and is susceptible to failure. Cost-efficient techniques to enhance stability of vaccines could prevent such losses and improve vaccination coverage, particularly in low income countries. We have previously reported a novel, potentially less expensive thermostabilisation approach using a combination of simple sugars and glass micro-fibrous matrix, achieving an excellent recovery of vaccines after storage at supraphysiological temperatures. This matrix is, however, prone to fragmentation and currently not suitable for clinical translation.Here, we report an investigation of alternative, potentially GMP compatible, fibrous matrices. A number of commercially-available matrices permitted good protein recovery, quality of sugar glass and moisture content of the dried product but did not achieve the thermostabilisation performance of the original glass fibre matrix. We therefore further investigated physical and chemical characteristics of the glass fibre matrix and its components. Our investigation shows that the polyvinyl alcohol present in the glass fibre matrix assists vaccine stability. This finding enabled us to develop a custom-produced matrix with encouraging performance, as an initial step towards a biocompatible matrix for clinical translation. We discuss the path to transfer of the technology into clinical use, including potential obstacles.

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Identification of Excipients for Stabilizing Fiberless Adenovirus as Biopharmaceuticals

Cited by 2 publications

References 42 publications

Characterisation of factors contributing to the performance of nonwoven fibrous matrices as substrates for adenovirus vectored vaccine stabilisation

Characterisation of factors contributing to the performance of nonwoven fibrous matrices as substrates for adenovirus vectored vaccine stabilisation

Characterisation of factors contributing to the performance of nonwoven fibrous matrices as substrates for adenovirus vectored vaccine stabilisation

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