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Development of a new magnetic bead platform for use in GMP production of mRNA vaccines
Get PDFThe success of mRNA vaccines in fighting the SARS-CoV-2 pandemic has brought the world into a new era of vaccine development. The production methods are not yet standardized and the need for flexible and highly scalable production of mRNA is still urgent.
We have previously presented our magnetic bead technology, including solid-phase in vitro transcription and generic capture purification on carboxylic acid activated beads, enabling different flexible strategies for scaling up mRNA production. The same technology is easily adapted from research scale volumes to industrial volumes.
For use in the manufacture of Therapeutic agents, there are high regulatory demands for documentation of both safety and performance of the technology. We are therefore developing a new Dynabeads magnetic bead platform and two new products, designed to be suitable as raw materials/ancillary materials for use in GMP manufacturing of mRNA vaccines. The beads are in compliance with ISO13485 and ISO20399 and regulatory support documentation will be available.
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Intensified high yield production of GMMA based vaccines for high burden neglected disease
Get PDFVaccines are among the most important public health interventions currently available. The global demand for vaccines is growing due to global population growth, ongoing global immunization campaigns and the increase of antibiotic-resistant bacteria. Vaccines are of high importance in Low- and Middle-Income Countries (LMIC) where millions of deaths occur annually due to vaccines-preventable diseases. Global coverage would need at least 200 million doses annually of a two-dose vaccine to cover the at-risk birth cohort, and considerably more for catch up vaccination during a roll out phase. Especially for vaccines against diseases in LMIC, there is a major added constraint: the vaccine production cost per unit and manufacturing facilities investments must be minimized to ensure the vaccines will be both viable and sustainable.
For diseases caused by Gram-negative bacteria, the vaccine platform based on the GMMA technology is promising. GMMA are highly immunogenic outer membrane exosomes produced from genetically engineered bacteria modified for high yield hyper-blebbing that can be purified with minimal downstream processing. Simple robust scalable processes make GMMA ideal for cost-conscious vaccines.
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Biomanufacturing using single use systems: Case study of fluoropolymer material
Get PDFIn this presentation, we will discuss recent biocompatibility data obtained using our gamma stable fluoropolymer platform and its advantage in a modern manufacturing environment for the handling of almost any biological fluids.
Single-use, disposable solutions are now widely accepted as gold standard in the biopharmaceutical industry covering every single steps of the drug manufacture process. From early-stage small scale R&D project, upstream production with several thousand-liters bioreactors, downstream process, API formulation up to critical fill & finish and transport applications, the industry is taking a shift with a significant breakthrough reported in 2021: the largest GMP facility in the world using single-use (from 200L to 4,000 L) bioreactors has been publicly announced this year with a global single-use bioreactor workforce of over 150,000 L (with extension plans for 2024 to expand its use of disposable bioreactors to over 430,000 L).
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Design of a vaccine against dengue and Zika viruses based on a mimotope of the envelope dimer epitope
Get PDFZika and dengue viruses are members of the Flavivirus genus that cause mild fever, rash and general body pain; but can cause severe reactions, as hemorrhages (dengue virus), congenital syndrome (Zika virus), or even death. Because of the structural similarity between these viruses, some antibodies generated after an infection can cross-react with different members of the flavivirus family. After a secondary infection, the cross-reactive antibodies can lead to more severe forms of the disease, through a mechanism named antibody-dependent enhancement of infection (ADE). Broadly neutralizing antibodies are antibodies that neutralize both, dengue and Zika viruses; and it has been demonstrated that they do not induce ADE. These antibodies are directed to a discontinuous quaternary epitope named the Envelope Dimer Epitope (EDE)1, located in the envelope (E) protein. To obtain the EDE, it is necessary to express the complete E protein, which contains other epitopes that induce ADE. This study aims to generate a peptide that emulates the EDE epitope structure (mimotope) in order to be used as a dual vaccine against dengue and Zika viruses; without causing ADE.
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Multivalent Influenza vaccine production in HEK-293 cells in response to pandemic threats
Get PDFInfluenza virus infects millions of people every year worldwide, with elderly and very young people among the most critically affected. Strains that constitute a pandemic threat are characterized by the severity of the clinical manifestations and mortality rates and tend to require the urgent production of hundreds of millions of vaccine doses in very short periods of time. There is an evident need to develop new generations of influenza vaccines based on robust production systems such as mammalian or insect cell cultures. These systems may allow, in contrast to production in embryonated chicken eggs, a faster response capacity, a superior manufacturing process control and a more reliable and better characterized product.
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Novel polymer-derived carbide and boride refractory ceramics
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Materials processing and property-structure characterization capabilities at The University of Alabama
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Mixing the transition metals in transition metal carbides
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Strategies for printing fibers and post-processing for ceramic matrix composites (CMCs)
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Laser additive manufacturing of ultra high temperature ceramics
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