Vacuum Foam Drying Method Improved the Thermal Stability and Long-Term Shelf Life of a Live Attenuated Newcastle Disease Virus Vaccine

Lyu, Fan; Zhao, Yue; Lu, Yu; Zuo, Xiaoxin; Deng, Bihua; Zeng, Min-qian; Wang, Junning; Olaniran, Ademola O.; Hou, Jingbo; Khoza, Thandeka

doi:10.1208/s12249-022-02440-4

Cited by 6 publications

(14 citation statements)

References 38 publications

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“…15−18 Currently, the predominant approaches employed to enhance the thermal stability of vaccines involve the utilization of stabilizers, such as polyethylene glycol (PEG), 19 glutamate, 20 and alginate, 21 as well as thermal stabilization techniques, including genetic engineering, 22 surface charge engineering, 23 freeze-drying, 24 spray-drying, 25 and foam-drying. 26 In recent years, several innovative approaches have been developed for the manufacture of vaccines that can withstand high temperatures, including the use of gold nanoparticles, 27 bacterial spores, 28 poly(lactic-co-glycolic acid) particles, 29 and virus-like particles. 30 Unfortunately, these approaches still rely on the cold chain or have intricate preparation processes, which limit their application.…”

Section: ■ Introductionmentioning

confidence: 99%

“…In addition, to prevent perinatal transmission of HBV, the World Health Organization recommends that infants receive their first dose of hepatitis B vaccine within 24 h of birth, but this is also a challenge in some remote areas or countries that lack or have an inadequate vaccine cold chain. Although some regions or countries, such as rural China, rural Vietnam, the Solomon Islands and Lao People’s Democratic Republic, have implemented strategies such as storing hepatitis B vaccines outside the cold chain to alleviate the burden on the cold chain, it remains essential to address the problem of the vaccine cold chain by fundamentally enhancing the thermal stability of vaccines. − Currently, the predominant approaches employed to enhance the thermal stability of vaccines involve the utilization of stabilizers, such as polyethylene glycol (PEG), glutamate, and alginate, as well as thermal stabilization techniques, including genetic engineering, surface charge engineering, freeze-drying, spray-drying, and foam-drying . In recent years, several innovative approaches have been developed for the manufacture of vaccines that can withstand high temperatures, including the use of gold nanoparticles, bacterial spores, poly(lactic- co -glycolic acid) particles, and virus-like particles .…”

Section: Introductionmentioning

confidence: 99%

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Silk Fibroin-Coated Nano-MOFs Enhance the Thermal Stability and Immunogenicity of HBsAg

Zhang,

Wang,

et al. 2024

ACS Appl. Mater. Interfaces

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Vaccines are widely regarded as one of the most effective weapons in the fight against infectious diseases. Currently, vaccines must be stored and transported at low temperatures as high temperatures can lead to a loss of vaccine conformation and reduced therapeutic efficacy. Metal−organic frameworks (MOFs), such as zeolitic imidazole framework-8 (ZIF-8), are a new class of hybrid materials with large specific surface areas, high loading rates, and good biocompatibility and are successful systems for vaccine delivery and protection. Silk fibroin (SF) has a good biocompatibility and thermal stability. In this study, the hepatitis B surface antigen (HBsAg) was successfully encapsulated in ZIF-8 to form HBsAg@ZIF-8 (HZ) using a one-step shake and one-pot shake method. Subsequently, the SF coating modifies HZ through hydrophobic interactions to form HBsAg/SF@ZIF-8 (HSZ), which enhanced the thermal stability and immunogenicity of HBsAg. Compared to free HBsAg, HZ and HSZ improved the thermostability of HBsAg, promoted the antigen uptake and lysosomal escape, stimulated dendritic cell maturation and cytokine secretion, formed an antigen reservoir to promote antibody production, and activated CD4 + T and CD8 + T cells to enhance memory T-cell production. Importantly, HSZ induced a strong immune response even after 14 days of storage at 25 °C. Furthermore, the nanoparticles prepared by the one-step shake method exhibited superior properties compared to those prepared by the one-pot shake method. This study highlights the importance of SF-coated ZIF-8, which holds promise for investigating thermostable vaccines and breaking the vaccine cold chain.

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Section: ■ Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Silk Fibroin-Coated Nano-MOFs Enhance the Thermal Stability and Immunogenicity of HBsAg

Zhang,

Wang,

et al. 2024

ACS Appl. Mater. Interfaces

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“…As a result, alternative innovative preservation strategies are continuously explored to mitigate the challenges of vaccine cold chain reliance (Crommelin et al 2021 ; Leung et al 2019 ). Previous small-scale studies have demonstrated that vacuum foam drying (VFD) improves the thermostability and long-term shelf life of the Newcastle disease virus (NDV) vaccine while maintaining its immunogenicity profile (Lyu et al 2022 ). This signifies a breakthrough in the development of cold-chain independent vaccines (Fanelli et al 2022 ; Lyu et al 2022 ).…”

Section: Introductionmentioning

confidence: 99%

“…Previous small-scale studies have demonstrated that vacuum foam drying (VFD) improves the thermostability and long-term shelf life of the Newcastle disease virus (NDV) vaccine while maintaining its immunogenicity profile (Lyu et al 2022 ). This signifies a breakthrough in the development of cold-chain independent vaccines (Fanelli et al 2022 ; Lyu et al 2022 ). However, the outcomes of small-scale bioprocesses do not always provide a reliable simulation of their large-scale equivalents due to differences in the physico-chemical dynamics of micro- and macro-environments that affect biological systems (Garcia-Ochoa and Gomez 2009 ).…”

Section: Introductionmentioning

confidence: 99%

“…Vaccine thermostability has a direct bearing on the shelf life and safety of the commercial product; therefore, it is important to consider the relationship between vaccine preservation methods and the feasibility of upscaling vaccine production (Bastos et al 2015 ; Butreddy et al 2020 ). Our previous study made a strong case for the use of VFD technology for the production of a robust, thermostable and immunogenic NDV vaccine (Lyu et al 2022 ). Likewise, there is more published literature to support the successful long-term stabilization of sensitive biological material using the VFD technique (Bronshtein et al 2001 ; Tlaxca et al 2015 ).…”

Section: Introductionmentioning

confidence: 99%

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Thermostable vacuum foam dried Newcastle disease vaccine: Process optimization and pilot-scale study

Lyu,

Zhao,

Zuo

et al. 2024

Appl Microbiol Biotechnol

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Vacuum foam drying (VFD) has been shown to improve the thermostability and long-term shelf life of Newcastle Disease Virus (NDV). This study optimized the VFD process to improve the shelf life of NDV at laboratory-scale and then tested the optimized conditions at pilot-scale. The optimal NDV to T5 formulation ratio was determined to be 1:1 or 3:2. Using the 1:1 virus to formulation ratio, the optimal filling volumes were determined to be 13–17% of the vial capacity. The optimized VFD process conditions were determined to be at a shelf temperature of 25℃ with a minimum overall drying time of 44 h. The vaccine samples prepared using these optimized conditions at laboratory-scale exhibited virus titer losses of ≤ 1.0 log10 with residual moisture content (RMC) below 3%. Furthermore, these samples were transported for 97 days around China at ambient temperature without significant titer loss, thus demonstrating the thermostability of the NDV-VFD vaccine. Pilot-scale testing of the NDV-VFD vaccine at optimized conditions showed promising results for up-scaling the process as the RMC was below 3%. However, the virus titer loss was slightly above 1.0 log10 (approximately 1.1 log10). Therefore, the NDV-VFD process requires further optimization at pilot scale to obtain a titer loss of ≤ 1.0 log10. Results from this study provide important guidance for possible industrialization of NDV-VFD vaccine in the future. Key points • The process optimization and scale-up test of thermostable NDV vaccine prepared through VFD is reported for the first time in this study. • The live attenuated NDV-VFD vaccine maintained thermostability for 97 days during long distance transportation in summer without cold chain conditions. • The optimized NDV-VFD vaccine preparations evaluated at pilot-scale maintained acceptable levels of infectivity after preservation at 37℃ for 90 days, which demonstrated the feasibility of the vaccine for industrialization.

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Vaccine process technology—A decade of progress

Buckland,

Sanyal,

Ranheim

et al. 2024

Biotech & Bioengineering

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In the past decade, new approaches to the discovery and development of vaccines have transformed the field. Advances during the COVID‐19 pandemic allowed the production of billions of vaccine doses per year using novel platforms such as messenger RNA and viral vectors. Improvements in the analytical toolbox, equipment, and bioprocess technology have made it possible to achieve both unprecedented speed in vaccine development and scale of vaccine manufacturing. Macromolecular structure‐function characterization technologies, combined with improved modeling and data analysis, enable quantitative evaluation of vaccine formulations at single‐particle resolution and guided design of vaccine drug substances and drug products. These advances play a major role in precise assessment of critical quality attributes of vaccines delivered by newer platforms. Innovations in label‐free and immunoassay technologies aid in the characterization of antigenic sites and the development of robust in vitro potency assays. These methods, along with molecular techniques such as next‐generation sequencing, will accelerate characterization and release of vaccines delivered by all platforms. Process analytical technologies for real‐time monitoring and optimization of process steps enable the implementation of quality‐by‐design principles and faster release of vaccine products. In the next decade, the field of vaccine discovery and development will continue to advance, bringing together new technologies, methods, and platforms to improve human health.

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Vacuum Foam Drying Method Improved the Thermal Stability and Long-Term Shelf Life of a Live Attenuated Newcastle Disease Virus Vaccine

Cited by 6 publications

References 38 publications

Silk Fibroin-Coated Nano-MOFs Enhance the Thermal Stability and Immunogenicity of HBsAg

Silk Fibroin-Coated Nano-MOFs Enhance the Thermal Stability and Immunogenicity of HBsAg

Thermostable vacuum foam dried Newcastle disease vaccine: Process optimization and pilot-scale study

Vaccine process technology—A decade of progress

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