Sustainable vaccine development: a vaccine manufacturer's perspective

Rappuoli, Rino; Hanon, Emmanuel

doi:10.1016/j.coi.2018.04.019

Cited by 27 publications

(21 citation statements)

References 64 publications

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“…Ever increasing demands for vaccination and gene therapy have raised the need to develop efficient large-scale manufacturing processes, including cell culture-based virus production (Kaemmerer 2018;Rappuoli and Hanon 2018). One option for intensified, rapid, and flexible biological manufacturing is high cell density perfusion cultures (Bielser et al 2018;Chen et al 2018).…”

Section: Introductionmentioning

confidence: 99%

Performance of an acoustic settler versus a hollow fiber–based ATF technology for influenza virus production in perfusion

Gränicher

Coronel

Trampler³

et al. 2020

Appl Microbiol Biotechnol

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Process intensification and integration is crucial regarding an ever increasing pressure on manufacturing costs and capacities in biologics manufacturing. For virus production in perfusion mode, membrane-based alternating tangential flow filtration (ATF) and acoustic settler are the commonly described cell retention technologies. While acoustic settlers allow for continuous influenza virus harvesting, the use of commercially available membranes for ATF systems typically results in the accumulation of virus particles in the bioreactor vessel. Accordingly, with one single harvest at the end of a cultivation, this increases the risk of lowering the product quality. To assess which cell retention device would be most suitable for influenza A virus production, we compared various key performance figures using AGE1.CR.pIX cells at concentrations between 25 and 50 × 10 6 cells/mL at similar infection conditions using either an ATF system or an acoustic settler. Production yields, process-related impurities, and aggregation of viruses and other large molecules were evaluated. Taking into account the total number of virions from both the bioreactor and the harvest vessel, a 1.5-3.0-fold higher volumetric virus yield was obtained for the acoustic settler. In addition, fewer large-sized aggregates (virus particles and other molecules) were observed in the harvest taken directly from the bioreactor. In contrast, similar levels of process-related impurities (host cell dsDNA, total protein) were obtained in the harvest for both retention systems. Overall, a clear advantage was observed for continuous virus harvesting after the acoustic settler operation mode was optimized. This development may also allow direct integration of subsequent downstream processing steps. Key points• High suspension cell density, immortalized avian cell line, influenza vaccine.

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Section: Introductionmentioning

confidence: 99%

Performance of an acoustic settler versus a hollow fiber–based ATF technology for influenza virus production in perfusion

Gränicher

Coronel

Trampler³

et al. 2020

Appl Microbiol Biotechnol

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“…As for other vaccine types, development of glycoconjugate vaccines is a long, complex and economically demanding process that can last up to 10-15 years [25,26]. The increasing complexity of future vaccines, and the need to shorten the time to their release onto market, have triggered the development of faster approaches to the design of glycoconjugate vaccines.…”

Section: Introductionmentioning

confidence: 99%

Glycoconjugate vaccines: current approaches towards faster vaccine design

Micoli¹,

Bino²,

Alfini³

et al. 2019

Expert Review of Vaccines

107

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Introduction: Over the last decades, glycoconjugate vaccines have been proven to be a successful strategy to prevent infectious diseases. Many diseases remain to be controlled, especially in developing countries, and emerging antibiotic-resistant bacteria present an alarming public-health threat. The increasing complexity of future vaccines, and the need to accelerate development processes have triggered the development of faster approaches to glycoconjugate vaccines design.Areas covered: This review provides an overview of recent progress in glycoconjugation technologies toward faster vaccine design. Expert opinion: Among the different emerging approaches, glycoengineering has the potential to combine glycan assembly and conjugation to carrier systems (such as proteins or outer membrane vesicles) in one step, resulting in a simplified manufacturing process and fewer analytical controls. Chemical and enzymatic strategies, and their automation can facilitate glycoepitope identification for vaccine design. Other approaches, such as the liposomal encapsulation of polysaccharides, potentially enable fast and easy combination of numerous antigens in the same formulation. Additional progress is envisaged in the near future, and some of these systems still need to be further validated in humans. In parallel, new strategies are needed to accelerate the vaccine development process, including the associated clinical trials, up to vaccine release onto the market.

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“…The development of vaccines from early development to the availability on the market is a timely process that can take more than 10 years with cost >$100 Million US Dollars (208). The licensure process is defined by EMA and FDA based on requirements that are either provided in the code of federal regulation 21 (CFR 21) or in guideline documents on the clinical evaluation of vaccines (EMEA/CHMP/VWP/164653/05).…”

Section: Regulatory Progress and Health Policy Framework In The Vaccine Development For Zika And Chikungunya Virusmentioning

confidence: 99%

Current Efforts in the Development of Vaccines for the Prevention of Zika and Chikungunya Virus Infections

et al. 2020

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Arboviruses represent major challenges to public health, particularly in tropical, and subtropical regions, and a substantial risk to other parts of the world as respective vectors extend their habitats. In recent years, two viruses transmitted by Aedes mosquitoes, Chikungunya and Zika virus, have gathered increased interest. After decades of regionally constrained outbreaks, both viruses have recently caused explosive outbreaks on an unprecedented scale, causing immense suffering and massive economic burdens in affected regions. Chikungunya virus causes an acute febrile illness that often transitions into a chronic manifestation characterized by debilitating arthralgia and/or arthritis in a substantial subset of infected individuals. Zika infection frequently presents as a mild influenza-like illness, often subclinical, but can cause severe complications such as congenital malformations in pregnancy and neurological disorders, including Guillain-Barré syndrome. With no specific treatments or vaccines available, vector control remains the most effective measure to manage spread of these diseases. Given that both viruses cause antibody responses that confer long-term, possibly lifelong protection and that such responses are cross-protective against the various circulating genetic lineages, the development of Zika and Chikungunya vaccines represents a promising route for disease control. In this review we provide a brief overview on Zika and Chikungunya viruses, the etiology and epidemiology of the illnesses they cause and the host immune response against them, before summarizing past and current efforts to develop vaccines to alleviate the burden caused by these emerging diseases. The development of the urgently needed vaccines is hampered by several factors including the unpredictable epidemiology, feasibility of rapid clinical trial implementation during outbreaks and regulatory pathways. We will give an overview of the current developments.

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Sustainable vaccine development: a vaccine manufacturer's perspective

Cited by 27 publications

References 64 publications

Performance of an acoustic settler versus a hollow fiber–based ATF technology for influenza virus production in perfusion

Performance of an acoustic settler versus a hollow fiber–based ATF technology for influenza virus production in perfusion

Glycoconjugate vaccines: current approaches towards faster vaccine design

Current Efforts in the Development of Vaccines for the Prevention of Zika and Chikungunya Virus Infections

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