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Development of a pentavalent Group B Streptococcus (GBS) glycoconjugate vaccine in Africa
Get PDFA vaccine against Group B Streptococcus (GBS), utilized in a maternal immunization strategy to reduce the burden of GBS mortality and morbidity in infants, has potential for use all over the world, but would have the greatest impact in low-resource countries that have limited access to interventions. Currently there is no vaccine against GBS. The Biovac Institute (Biovac), a private public partnership in South Africa, is developing a pentavalent, polysaccharide-protein conjugate vaccine (PCV) against GBS — using state-of-the-art technology and targeting the most common strains.
A vaccine providing more than 90 % coverage against GBS infection would need to include at least 5 serotypes including serotypes Ia, Ib, II, III and V. Production of a low-cost pentavalent vaccine would require optimization of unit processes to achieve high yields without compromising product quality.
The presentation will describe (1) the selection of high capsular polysaccharide (CPS) producing isolates; (2) development of manufacturing processes to produce CPS for serotypes Ia, Ib, II, III and V; (3) development of a glycoconjugate process, which involves covalently linking the CPS to a carrier protein; (4) results of a monovalent conjugate vaccine mouse study; and (5) further animal and clinical studies planned.
While the GBS project affords Biovac the opportunity to establish end-to-end vaccine product development capability, equally importantly, it will also begin to shift the paradigm regarding Africa by demonstrating that vaccine projects of this complexity and magnitude can be done in Africa by Africans. It will contribute significantly to advancing Africa’s capability to respond to vaccine epidemics and infectious diseases of regional relevance
A novel SARS-CoV-2 (T Cell) vaccine candidate designed using the iVAX platform
Get PDFEpiVax, Inc., a Rhode Island-based Biotechnology company, develops vaccines that exploit T cell immunity using the innovative iVAX vaccine antigen design platform. The premise of our strategy is the crucial role T cells play in development of protective antibody and cell-mediated immunity in natural infection. Because vaccines aim to recapitulate protective immune responses in infection, a vaccine should effectively harness T cell immunity to be protective. The significance of T cell immunity is underscored by COVID-19. Efficacy trial and real-world COVID-19 vaccine data for different vaccine modalities show a single vaccine dose is as much as 90% effective starting 14 days post-administration, when 100% of vaccinees have functional CD4 and CD8 T cells but no detectable neutralizing antibodies. As T cells support the SARS-CoV-2 antibody response, clear virus-infected cells, and may be required to block transmission, we set out to develop a vaccine designed by iVAX to enhance T cell immunity and provide long lasting protection.
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Intensification of influenza virus production in fed-batch and perfusion cultures of HEK293SF cells
Get PDFMore than half a million people die every year from complications of seasonal influenza, and vaccination stands as the most effective method to prevent and limit outbreaks of the disease. Constant vaccine development based on emerging strains and worldwide distribution of vaccines is a great challenge for public health and vaccine manufacturers, particularly in a potential pandemic scenario. The limited flexibility of the current egg-based production system combined with recent advances in large-scale cell culture techniques have encouraged the development of cell culture processes for influenza vaccine production. While cell culture offers a valuable alternative, productivities are still low when compared to traditional egg-based systems, requiring extensive efforts in process intensification and suspension cell line development.
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Suspension Vero cell culture technology for high titer production of viral vaccines
Get PDFVero cells are considered as the most widely accepted continuous cell line by the regulatory authorities (such as WHO) for the manufacture of viral vaccines for human use. The continuous Vero cell line has been commercially used, after propagation on microcarriers, for the production of rabies, polio, enterovirus 71, hantaan, more recent COVID19 and other vaccines. Vero cell culture technologies were also explored for productions of many more viral vaccines over the last two decades. The growth of Vero cells is anchorage-dependent, and cells need to be dissociated enzymatically or mechanically for the process of subcultivation. This process is labor intensive and complicated in process scale-up. Adaptation of Vero cells to grow in suspension will significantly simplify scale-up and manufacturing processes. Development of advanced suspension Vero culture technology to improve product titer will further reduce the cost of goods.
We previously reported a successful adaptation of adherent Vero cells originated from ATCC CCL-81 to grow in suspension in serum-free and animal component-free media developed in-house. The suspension adapted cells were found to retain their genetic stability and to be non-tumorigenic. Present work continues the development and optimization of cell culture process and feeding strategy to improve the growth of suspension Vero cell and the production of vesicular stomatitis virus (VSV) and herpes simplex virus-1 (HSV-1). Data from this study showed the suspension adapted Vero cells retained similar VSV productivity to that obtained in adherent culture; volumetric productivity of VSV increased with the increasing cell density at infection in batch culture. However, the maximum cell density in batch culture was about 2.5x106 cells/mL, and was not improved significantly despite tremendous effort dedicated to improve culture conditions such as supplementing various nutrients in batch culture. As a result, perfusion culture was employed as an approach to increase cell density in the culture, which in turn increased the VSV productivity up to one log, at 1.1x1010 TCID50/mL when the culture infected at 7x106 cells/mL.
High titer production of HSV-1 in the Vero culture is more challenging. The virus productivity is not only limited by the maximum cell density in batch culture, but also reduced by inhibitory metabolites secreted in the culture even at low cell density such as 1x106 cells/mL. Media replacement before virus infection is essential to achieve a high HSV-1 yield. As such, perfusion culture was a preferred mode for high titer production of HSV-1, which improved the HSV-1 titer also by up to one log to 1.8 x109 TCID50/ in a culture infected at 5x106 cells/mL when comparing to a control shake flask culture infected at 1x106 cells/mL. Experimental data also demonstrated that perfusion Vero culture was robust and reproducible.
This study demonstrates that batch or perfusion suspension Vero culture is a much simplified process than current adherent culture technology for manufacturing of viral vaccines, and offers great potentials in reducing the cost of goods. The suspension Vero culture developed in our institute has generated tremendous interests from industry and academia, and are being tested by many different organizations
High Density HEK293T culture for high yield, high quality, stable adenoviral vector production in Ambr® 250 stirred tank reactors
Get PDFAdenovirus vectors (AdV) present high safety and immunogenicity for drug development, allowing more and more vaccines to adopt this technology platform in recent years. Due to the current COVID-19 pandemic, the global demand for AdV has experienced significant growth. Therefore, to optimize the upstream process in order to obtain high yields, good quality and stable viral vectors, it becomes critical that processes are stable and easy to scale-up, which has become a key focus of pharmaceutical companies in the field.
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Production of influenza virus-like particles by insect cells and removal of baculovirus from virus-like particles and other extracellular vesicles
Get PDFEnveloped virus-like particles (eVLPs) are a complementary strategy for the manufacturing of vaccines against enveloped viruses. The baculovirus expression vector system (BEVS) in insect cells is an attractive and widely used platform for the expression of eVLPs. Inherent to this system is the co-expression of baculoviruses and other extracellular vesicles, which we could nicely demonstrate by high resolution electron microscopy on one of our expression supernatants (Figure 1). Such heterogenous sample mixtures pose a major bottleneck for effective downstream processing of insect cell-expressed enveloped virus-like particles. eVLPs, baculoviruses and extracellular vesicles are similar in size and share a lot of common surface properties which make chromatographic separation difficult. In addition, immune responses against baculoviruses have been reported in humans, therefore efficient removal is mandatory.
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Environmental conical nozzle levitator equipped with dual lasers
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Integrated self-healing thermal protection for high-speed vehicles
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Additive manufacturing enabling W-SiC and W-ZrB2-SiC heterogeneous materials
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Thermal ablation behaviour of ultra-high temperature ceramic matrix composites made by RF enhanced chemical vapour infiltration
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