Clarification of vaccines: An overview of filter based technology trends and best practices

Besnard, Lise; Fabre, Virginie; Fettig, Michael; Gousseinov, Elina; Kawakami, Yoshimi; Laroudie, Nicolas; Scanlan, Claire; Pattnaik, Priyabrata

doi:10.1016/j.biotechadv.2015.11.005

Cited by 74 publications

(74 citation statements)

References 75 publications

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“…DLS is a non-invasive diagnostic tool for particle sizing and determination of particle size distribution in solutions or colloidal dispersions [50]. From DLS measurements, diffusion coefficient can be obtained from analysis of time-dependent fluctuations of scattered light intensity arising from particles undergoing random Brownian motion [40,51].…”

Section: Validation Of the Dls Methodsmentioning

confidence: 99%

“…Nevertheless, their efficacy in selected low-income countries, where they are needed most, was low during clinical trials and post-licensure studies [19,49]. The reasons for their lower efficacy in developing countries may be due to high levels of maternal antibodies, mixed infections with various pathogens in the gut, a higher rate of malnutrition, regional differences in prevalent RV genotypes and serotypes, and emergence of potentially virulent strains via reassortment of RVs between vaccine strains and circulating wild type strains [19,47,50]. Their attenuated live nature has raised concerns related to viral shading and risk of reversion and transmission [51].…”

Section: The Current Vaccine Paradigmmentioning

confidence: 99%

“…Antibody to NSP4 can block diarrhoea via its anti-enterotoxin activity, but cannot prevent viral infection [50]. For example, mouse dams fed transgenic potato tuber expressing cholera toxin-murine RV NSP4 aa114-135 peptide fusion protein were found to develop NSP4-specific serum and intestinal antibodies.…”

Section: Immunity To Rotavirusmentioning

confidence: 99%

“…Briefly, concentrated stock solutions of additives listed in Table 1 were made in a buffer containing 40 mM tris-base, 1 mM ethylenediaminetetra-acetic acid (EDTA) disodium and 5% (v/v) glycerol. The additives were dissolved completely and filtered through 0.22 µm filter membrane [50]. The buffer was adjusted to (Table 1) and one microliter of thrombin (40 U/mL) (GE Healthcare) were mixed in 1.5 mL polypropylene Eppendorf tubes (Sarstedt, Australia).…”

Section: Enzyme-mediated Release Of the Gst Tagmentioning

confidence: 99%

“…One possibility is the hydrophobic-hydrophobic interactions between surface exposed RV10 elements, driving the formation of aggregates. Poor capsomere and VLP stability can also arise due to module insertion, causing a reduction of stabilization energy [50]. Thus, this necessitates specific design of RV10 modules that will maintain capsomeres stability in compatible VLP assembly buffer.…”

Section: Novex ® Sharp Pre-stained Protein Marker (M) Was Used As a Lmentioning

confidence: 99%

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Virus-like particle and capsomere vaccines against rotavirus

Mogus¹

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Rotavirus is the major enteric pathogen that is responsible for more than 500,000 deaths of children worldwide annually. The use of live-attenuated oral rotavirus vaccines has significantly reduced child mortality rate in developed countries. However, the situation still remains unacceptably worse in most developing countries due to low efficacy of the vaccines in the region. The vaccines often do not reach the developing countries due to financial and logistic challenges.A high burden of rotavirus disease and the unresolved challenges with the current rotavirus vaccines, particularly in developing countries, have ignited efforts to develop next-generation lowcost, effective and safe vaccine candidates. Virus-like particles (VLPs) have come into focus for their promising application in vaccination because of their unique and attractive set of properties including safety, self-adjuvanticity, developability, economy and the ability to be formulated for stability without a cold chain. Their impact on human health is already evident through commercialization of VLP vaccines against hepatitis B virus infection, human papillomavirusinduced cervical cancer and hepatitis E virus infection. Rotavirus-like particles (RLPs) with proven preclinical immunogenicity and protective efficacy are considered as safe and effective vaccine candidates. While RLPs comprising multiple viral proteins can be difficult to process, modular VLPs presenting rotavirus antigenic modules are promising approaches in reducing process complexity and cost. Depending on the physicochemical properties, size and /or surface density of modules, modularization may affect production of stable VLP forming subunits, termed capsomeres, and prevent VLP assembly. This thesis demonstrates a multipronged approach for a low-cost production of stable bacterially-produced modular murine polyomavirus capsomeres and in vitro assembled VLPs presenting a rotavirus highly conserved peptide epitope (RV10) and a conformational and a virus neutralizing 18 kDa antigen (VP8*), separately. The experimental works in this thesis were carried out to address challenges associated with the adverse effects of inserted module's physicochemical properties, size and density on the production of modular capsomeres and VLPs. Particularly, the expression and purification of stable modular capsomeres for in vitro modular VLP assembly and the enhancement of module-specific immune response were investigated. The outcomes of the work in this thesis are: (i) a rapid and simple high-throughput screening method based on dynamic light scattering measurements was developed to identify additives for enhanced stability of modular capsomeres; (ii) using synthetic biology designs, the hydrophobicity of RV10 modules was engineered for enhanced stability of modular capsomeres; (iii) in vitro assembled modular VLPs displaying RV10 modules were obtained via a module titration approach using Escherichia coli protein co-expression strategy; and (iv) highly stable and iii immunogenic modular VLPs d...

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Section: Validation Of the Dls Methodsmentioning

confidence: 99%

Section: The Current Vaccine Paradigmmentioning

confidence: 99%

Section: Immunity To Rotavirusmentioning

confidence: 99%

Section: Enzyme-mediated Release Of the Gst Tagmentioning

confidence: 99%

Section: Novex ® Sharp Pre-stained Protein Marker (M) Was Used As a Lmentioning

confidence: 99%

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Virus-like particle and capsomere vaccines against rotavirus

Mogus¹

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Adaptation of an rVSV Ebola vaccine purification process for rapid development of a viral vaccine candidate for SARS‐CoV‐2

Kuczynski,

Shallow,

Watson

et al. 2023

Biotechnology Journal

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During the COVID‐19 pandemic, long development timelines typically associated with vaccines were challenged. The urgent need for a vaccine provided a strong driver to reevaluate existing vaccine development approaches. Innovative approaches to regulatory approval were realized, including the use of platform‐based technology. In collaboration with the International AIDS Vaccine Initiative, Inc. (IAVI), Merck & Co., Inc., Rahway, NJ, USA rapidly advanced an investigational SARS‐CoV‐2 vaccine based on the recombinant vesicular stomatitis virus (rVSV) platform used for the Ebola vaccine ERVEBO (rVSV∆G‐ZEBOV‐GP). An rVSV∆G‐SARS‐CoV‐2 vaccine candidate was generated using the SARS‐CoV‐2 spike protein to replace the VSV G protein. The purification process development for this vaccine candidate was detailed in this paper. Areas were highlighted where the ERVEBO platform process was successfully adopted and where additional measures were needed for the SARS‐CoV‐2 vaccine candidate. These included: (i) endonuclease addition directly into the bioreactor prior to harvest, (ii) inclusion of a core‐shell chromatography step for improved purification, and (iii) incorporation of a terminal, sterile filtration step to eliminate the need for aseptic, closed processing. High infectious virus titers were achieved in Phase 3 clinical drug substance (>108 PFU mL−1), and process consistency was demonstrated across four large scale batches that were completed in 6 months from clone selection.

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Integrated molecular and bioprocess engineering for bacterially produced immunogenic modular virus‐like particle vaccine displaying 18 kDa rotavirus antigen

Tekewe

Fan

Tan

et al. 2016

Biotech & Bioengineering

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A high global burden of rotavirus disease and the unresolved challenges with the marketed rotavirus vaccines, particularly in the developing world, have ignited efforts to develop virus-like particle (VLP) vaccines for rotavirus. While rotavirus-like particles comprising multiple viral proteins can be difficult to process, modular VLPs presenting rotavirus antigenic modules are promising alternatives in reducing process complexity and cost. In this study, integrated molecular and bioprocess engineering approaches were used to simplify the production of modular murine polyomavirus capsomeres and VLPs presenting a rotavirus 18 kDa VP8* antigen. A single construct was generated for dual expression of non-tagged murine polyomavirus capsid protein VP1 and modular VP1 inserted with VP8*, for co-expression in Escherichia coli. Co-expressed proteins assembled into pentameric capsomeres in E. coli. A selective salting-out precipitation and a polishing size exclusion chromatography step allowed the recovery of stable modular capsomeres from cell lysates at high purity, and modular capsomeres were successfully translated into modular VLPs when assembled in vitro. Immunogenicity study in mice showed that modular capsomeres and VLPs induced high levels of VP8*-specific antibodies. Our results demonstrate that a multipronged synthetic biology approach combining molecular and bioprocess engineering enabled simple and low-cost production of highly immunogenic modular capsomeres and VLPs presenting conformational VP8* antigenic modules. This strategy potentially provides a cost-effective production route for modular capsomere and VLP vaccines against rotavirus, highly suitable to manufacturing economics for the developing world. Biotechnol. Bioeng. 2017;114: 397-406. © 2016 Wiley Periodicals, Inc.

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Clarification of vaccines: An overview of filter based technology trends and best practices

Cited by 74 publications

References 75 publications

Virus-like particle and capsomere vaccines against rotavirus

Virus-like particle and capsomere vaccines against rotavirus

Adaptation of an rVSV Ebola vaccine purification process for rapid development of a viral vaccine candidate for SARS‐CoV‐2

Integrated molecular and bioprocess engineering for bacterially produced immunogenic modular virus‐like particle vaccine displaying 18 kDa rotavirus antigen

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