Stability of lyophilized and spray dried vaccine formulations

Preston, Kendall B.; Randolph, Theodore W.

doi:10.1016/j.addr.2021.01.016

Cited by 67 publications

(37 citation statements)

References 106 publications

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“…Despite of a salt crystal being a rather dry environment, enveloped viruses are known to be able to survive long periods of time in dry conditions. This was already known for the vaccinia virus [13], and actually spray drying is currently used to preserve vaccines based on viral liposome vectors [29]. As we have shown in Fig.…”

Section: Discussionmentioning

confidence: 83%

Stability of Respiratory-Like Droplets under Evaporation

Seyfert¹,

Rodríguez-Rodríguez²,

Lohse³

et al. 2021

Preprint

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Pathogens contained in airborne respiratory droplets have been seen to remain infectious for periods of time that depend on the ambient temperature and humidity. In particular, regarding the humidity, the empirically least favorable conditions for the survival of viral pathogens are found at intermediate humidities. However, the precise physico-chemical mechanisms that generate such least-favorable conditions are not understood yet. In this work, we analyze the evaporation dynamics of respiratory-like droplets in air, semi-levitating them on superhydrophobic substrates with minimal solid-liquid contact area. Our results reveal that, compared to pure water droplets, the salt dissolved in the droplets can significantly change the evaporation behaviour, especially for high humidities close to and above the deliquesence limit. Due to the hygroscopic properties of salt, water evaporation is inhibited once the salt concentration reaches a critical value that depends on the relative humidity. The salt concentration in a stable droplet reaches its maximum at around 75% relative humidity, generating conditions that might shorten the time in which pathogens remain infectious.

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Section: Discussionmentioning

confidence: 83%

Stability of Respiratory-Like Droplets under Evaporation

Seyfert¹,

Rodríguez-Rodríguez²,

Lohse³

et al. 2021

Preprint

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“…For example, mRNA vaccines should be preserved at −20 °C to maintain their functions. Of note, lyophilized powder with cryoprotectant usually could be stored for years without losing its efficacy ( 32 , 33 ). Thus, three commonly used cryoprotectants—sucrose, trehalose, and mannitol—were usually used as the candidates to prepare the dry formulation of NCs.…”

Section: Resultsmentioning

confidence: 99%

Inhalable nanocatchers for SARS-CoV-2 inhibition

Zhang

Zhu

Jin

et al. 2021

Proc. Natl. Acad. Sci. U.S.A.

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The global coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome (SARS)–like coronavirus (SARS-CoV-2), presents an urgent health crisis. More recently, an increasing number of mutated strains of SARS-CoV-2 have been identified globally. Such mutations, especially those on the spike glycoprotein to render its higher binding affinity to human angiotensin-converting enzyme II (hACE2) receptors, not only resulted in higher transmission of SARS-CoV-2 but also raised serious concerns regarding the efficacies of vaccines against mutated viruses. Since ACE2 is the virus-binding protein on human cells regardless of viral mutations, we design hACE2-containing nanocatchers (NCs) as the competitor with host cells for virus binding to protect cells from SARS-CoV-2 infection. The hACE2-containing NCs, derived from the cellular membrane of genetically engineered cells stably expressing hACE2, exhibited excellent neutralization ability against pseudoviruses of both wild-type SARS-CoV-2 and the D614G variant. To prevent SARS-CoV-2 infections in the lung, the most vulnerable organ for COVID-19, we develop an inhalable formulation by mixing hACE2-containing NCs with mucoadhesive excipient hyaluronic acid, the latter of which could significantly prolong the retention of NCs in the lung after inhalation. Excitingly, inhalation of our formulation could lead to potent pseudovirus inhibition ability in hACE2-expressing mouse model, without imposing any appreciable side effects. Importantly, our inhalable hACE2-containing NCs in the lyophilized formulation would allow long-term storage, facilitating their future clinical use. Thus, this work may provide an alternative tactic to inhibit SARS-CoV-2 infections even with different mutations, exhibiting great potential for treatment of the ongoing COVID-19 epidemic.

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“…Freeze-drying, or lyophilization, is another technique used to stabilize vaccines, which is used for approximately 25% of the vaccines approved by the FDA ( Preston and Randolph 2021 ). The advantages of using freeze-drying are minimizing the damage to vaccines via the application of very low temperature during the processing and the ease of reconstituting the dry product.…”

Section: Conventional Methods In Developing Oral Vaccinesmentioning

confidence: 99%