Advances in Vaccine Biomanufacturing Processes

A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "Influenza Virus Vaccines".

Deadline for manuscript submissions: closed (20 April 2022) | Viewed by 7726

Special Issue Editor


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Guest Editor
Department of Chemical Engineering, Polytechnique Montréal, Montréal, QC, Canada
Interests: recombinant proteins; viral vectors; vaccines; animal cell culture; bioprocess development, optimization and control
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Special Issue Information

Dear Colleagues,

Continuous improvement of vaccine manufacturing processes is essential to meeting the needs of the growing global market. In this context, further research and development efforts are still needed to address the critical process and analytical challenges faced by biomanufacturers to speed up the production of safe, potent and cost-effective vaccines. The aim of this Special Issue is to present significant advances made in bioprocessing for the robust, rapid, flexible and cost-efficient manufacturing of vaccines. Contributions on a range of themes are welcome, including process intensification of upstream and downstream operations to improve productivity and increase product yield and purity, the development and application of new process analytical technologies to support process development and analyses of product quality attributes, the design of novel monitoring tools and control strategies to ensure process consistency and performance, the application of new high-throughput technologies and Quality-by-Design approaches for vaccine manufacturing, and devising new cell line platforms, innovative bioreactor designs and downstream processing techniques. Since rational process development and optimization are highly dependent on a good understanding of the complex production steps and interactions between cells and viruses, contributions related to the modeling of cell culture kinetics, as well as the application of systems biology and metabolic engineering approaches, are also welcome.

Prof. Dr. Olivier Henry
Guest Editor

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Keywords

  • vaccine manufacturing
  • process intensification
  • upstream process development
  • downstream processing
  • process analytical technologies

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Published Papers (2 papers)

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Research

9 pages, 1930 KiB  
Article
Establishment of Sandwich ELISA for Quality Control in Rotavirus Vaccine Production
by Cao Li, Guoxing Luo, Yuanjun Zeng, Feibo Song, Han Yang, Shiyin Zhang, Yingbin Wang, Tingdong Li, Shengxiang Ge and Ningshao Xia
Vaccines 2022, 10(2), 243; https://doi.org/10.3390/vaccines10020243 - 5 Feb 2022
Cited by 3 | Viewed by 2790
Abstract
Non-replicating rotavirus vaccines are alternative strategies that may improve the protective efficacy of rotavirus vaccines in low- and middle-income countries. The truncated spike protein VP4 (aa26-476, VP4*)was a candidate antigen for the development of recombinant rotavirus vaccines, with higher immunogenicity and protective efficacy [...] Read more.
Non-replicating rotavirus vaccines are alternative strategies that may improve the protective efficacy of rotavirus vaccines in low- and middle-income countries. The truncated spike protein VP4 (aa26-476, VP4*)was a candidate antigen for the development of recombinant rotavirus vaccines, with higher immunogenicity and protective efficacy compared to VP8* and VP5* alone. This article describes the development of three genotype-specific sandwich ELISAs for P[4], P[6], and P[8]-VP4*, which are important for quality control in rotavirus vaccine production. Our results showed that the detection systems had good specificity for the different genotype VP4* and were not influenced by the E. coli host proteins. Moreover, the detection systems play an important role in determining whether the target protein was contaminated by VP4* proteins of other genotypes. They can also detect the adsorption rate of the adjuvant to the P[4], P[6], P[8]-VP4* protein during the process development. The three detection systems will play an important role in the quality control and process development of VP4* based rotavirus vaccines and facilitate the development of recombinant rotavirus vaccines. Full article
(This article belongs to the Special Issue Advances in Vaccine Biomanufacturing Processes)
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16 pages, 3136 KiB  
Article
Process Development for Newcastle Disease Virus-Vectored Vaccines in Serum-Free Vero Cell Suspension Cultures
by Julia Puppin Chaves Fulber, Omar Farnós, Sascha Kiesslich, Zeyu Yang, Shantoshini Dash, Leonardo Susta, Sarah K. Wootton and Amine A. Kamen
Vaccines 2021, 9(11), 1335; https://doi.org/10.3390/vaccines9111335 - 16 Nov 2021
Cited by 16 | Viewed by 4259
Abstract
The ongoing COVID-19 pandemic drew global attention to infectious diseases, attracting numerous resources for development of pandemic preparedness plans and vaccine platforms—technologies with robust manufacturing processes that can quickly be pivoted to target emerging diseases. Newcastle Disease Virus (NDV) has been studied as [...] Read more.
The ongoing COVID-19 pandemic drew global attention to infectious diseases, attracting numerous resources for development of pandemic preparedness plans and vaccine platforms—technologies with robust manufacturing processes that can quickly be pivoted to target emerging diseases. Newcastle Disease Virus (NDV) has been studied as a viral vector for human and veterinary vaccines, but its production relies heavily on embryonated chicken eggs, with very few studies producing NDV in cell culture. Here, NDV is produced in suspension Vero cells, and analytical assays (TCID50 and ddPCR) are developed to quantify infectious and total viral titer. NDV-GFP and NDV-FLS (SARS-CoV-2 full-length spike protein) constructs were adapted to replicate in Vero and HEK293 suspension cultures using serum-free media, while fine-tuning parameters such as MOI, temperature, and trypsin concentration. Shake flask productions with Vero cells resulted in infectious titers of 1.07 × 108 TCID50/mL for NDV-GFP and 1.33 × 108 TCID50/mL for NDV-FLS. Production in 1 L batch bioreactors also resulted in high titers in culture supernatants, reaching 2.37 × 108 TCID50/mL for NDV-GFP and 3.16 × 107 TCID50/mL for NDV-FLS. This shows effective NDV production in cell culture, building the basis for a scalable vectored-vaccine manufacturing process that can be applied to different targets. Full article
(This article belongs to the Special Issue Advances in Vaccine Biomanufacturing Processes)
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