This challenge focuses on innovations in vaccine manufacturing platforms designed to lower production cost for vaccines that target diseases of great global burden and that are among the most costly to produce with current technologies.
Vaccines are one of the most powerful and effective health interventions ever developed, and also provide tremendous economic and societal value in averted costs, productivity gains, and poverty reduction. Yet a number of factors interact to limit complete global immunization coverage, and among those is the cost of procuring and distributing vaccines in lower income countries. A substantial reduction in the cost of manufacturing vaccines could help enable affordable, equitable and sustainable immunization on a global scale, while also enabling manufacturers to develop sustainable business models around such products. To that end, the foundation is soliciting innovative proposals to develop manufacturing platforms that can transform production economics and produce vaccines at a final finished goods production cost of ≤ $0.15 per dose. The proposed research and development will focus on at least one of the following: human papillomavirus, inactivated poliovirus, measles-rubella, pentavalent, pneumococcal, or rotavirus vaccine. The ultimate goal of this challenge is to significantly increase global access to priority vaccines by lowering the manufacturing cost required to produce them.

Vaccine Manufacturing RFP

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This challenge focuses on innovations in vaccine manufacturing platforms designed to lower production cost for vaccines that target diseases of great global burden and that are among the most costly to produce with current technologies. Vaccines are one of the most powerful and effective health interventions ever developed, and also provide tremendous economic and societal value in averted costs, productivity gains, and poverty reduction. Yet a number of factors interact to limit complete global immunization coverage, and among those is the cost of procuring and distributing vaccines in lower income countries. A substantial reduction in the cost of manufacturing vaccines could help enable affordable, equitable and sustainable immunization on a global scale, while also enabling manufacturers to develop sustainable business models around such products. To that end, the foundation is soliciting innovative proposals to develop manufacturing platforms that can transform production economics and produce vaccines at a final finished goods production cost of ≤ $0.15 per dose. The proposed research and development will focus on at least one of the following: human papillomavirus, inactivated poliovirus, measles-rubella, pentavalent, pneumococcal, or rotavirus vaccine. The ultimate goal of this challenge is to significantly increase global access to priority vaccines by lowering the manufacturing cost required to produce them.

Vaccine Manufacturing

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The Bill &amp; Melinda Gates Foundation is launching a new Grand Challenge: Innovations in Vaccine Manufacturing for Global Markets. This challenge focuses on innovations in vaccine manufacturing platforms designed to lower production cost for vaccines that target diseases of great global burden and that are among the most costly to produce with current technologies.&nbsp;
Vaccines are one of the most powerful and effective health interventions ever developed, and also provide tremendous economic and societal value in averted costs, productivity gains, and poverty reduction. Yet a number of factors interact to limit complete global immunization coverage, and among those is the cost of procuring and distributing vaccines in lower income countries. A substantial reduction in the cost of manufacturing vaccines could help enable affordable, equitable and sustainable immunization on a global scale, while also enabling manufacturers to develop sustainable business models around such products. To that end, the foundation is soliciting innovative proposals to develop manufacturing platforms that can transform production economics and produce vaccines at a final finished goods production cost of ≤ $0.15 per dose. The proposed research and development will focus on at least one of the following: human papillomavirus, inactivated poliovirus, measles-rubella, pentavalent, pneumococcal, or rotavirus vaccine. The ultimate goal of this challenge is to significantly increase global access to priority vaccines by lowering the manufacturing cost required to produce them.

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New Interventions for Global Health: Vaccine Manufacturing

José Castillo of Univercells in Belgium will create a compact low-cost and automated vaccine manufacturing platform by integrating three new technologies to produce more affordable vaccines at around 0.15USD per dose. Vaccine doses are generally 1-10USD most of which is due to inefficient production and high manufacturing costs including the need for major infrastructure. This relatively high cost prohibits their widespread use particularly in developing countries with limited funds. Starting with an inactivated poliovirus vaccine they will design and develop a compact high cell density bioreactor that concentrates vaccine production and high affinity capture membranes to streamline purification. They will house the technologies in a compact series of isolators that can be accommodated in a smaller laboratory space and perform pilot testing at a manufacturer's site to evaluate productivity and analyze purity and concentration of the vaccine.

José Castillo of Univercells in Belgium will create a compact low-cost and automated vaccine manufacturing platform by integrating three new technologies to produce more affordable vaccines at around 0.15USD per dose. Vaccine doses are generally 1-10USD most of which is due to inefficient production and high manufacturing costs including the need for major infrastructure. This relatively high cost prohibits their widespread use particularly in developing countries with limited funds. Starting with an inactivated poliovirus vaccine they will design and develop a compact high cell density bioreactor that concentrates vaccine production and high affinity capture membranes to streamline purification. They will house the technologies in a compact series of isolators that can be accommodated in a smaller laboratory space and perform pilot testing at a manufacturer's site to evaluate productivity and analyze purity and concentration of the vaccine.

Development of a Cost-Effective Automated Vaccine Manufacturing System Combining Vero Cell Lines High-Density Bioreactor and High-Performance Membrane Purification Platform in a Self-Contained Miniaturized Facility

Tarit Mukhopadhyay of University College London in the United Kingdom will develop a manufacturing platform to reduce the production costs of recombinant protein vaccines. Current manufacturing procedures involve serial batch operations in large complex facilities requiring highly trained operators and extensive testing and are inefficient and costly. They will build a platform that integrates and automates key steps to reduce labor costs and capital expenditure and improves product design and control procedures to reduce quality control requirements. Their aim is to maximize the number of doses with the minimal starting material leading to recombinant subunit vaccines at 0.15USD per dose rather than the current costs of several USD per dose. They will develop their approach initially using a rotavirus vaccine candidate.

Tarit Mukhopadhyay of University College London in the United Kingdom will develop a manufacturing platform to reduce the production costs of recombinant protein vaccines. Current manufacturing procedures involve serial batch operations in large complex facilities requiring highly trained operators and extensive testing and are inefficient and costly. They will build a platform that integrates and automates key steps to reduce labor costs and capital expenditure and improves product design and control procedures to reduce quality control requirements. Their aim is to maximize the number of doses with the minimal starting material leading to recombinant subunit vaccines at 0.15USD per dose rather than the current costs of several USD per dose. They will develop their approach initially using a rotavirus vaccine candidate.

Ultra Low-cost Transferable Automated (ULTRA) Platform for Vaccine Manufacturing

Michael Schrader of Vaxess Technologies Inc. in the U.S. will develop a microneedle patch that stabilizes vaccines and can deliver multiple doses through the skin at defined times thereby reducing cost waste and the need for repeat immunizations. Vaccinations delivered intradermally via microneedles are at least as effective as intramuscular delivery via injection but reduce the requirement for needles and trained health workers. The patch uses a silk fibroin protein that protects the vaccine against high temperatures removing the need for cold storage and controls the timing of release through the skin. They will refine the material for delivering two doses of inactivated poliovirus vaccine evaluate its safety and activity in animal models and optimize the manufacturing process to ensure reduced costs.

Michael Schrader of Vaxess Technologies Inc. in the U.S. will develop a microneedle patch that stabilizes vaccines and can deliver multiple doses through the skin at defined times thereby reducing cost waste and the need for repeat immunizations. Vaccinations delivered intradermally via microneedles are at least as effective as intramuscular delivery via injection but reduce the requirement for needles and trained health workers. The patch uses a silk fibroin protein that protects the vaccine against high temperatures removing the need for cold storage and controls the timing of release through the skin. They will refine the material for delivering two doses of inactivated poliovirus vaccine evaluate its safety and activity in animal models and optimize the manufacturing process to ensure reduced costs.

Dissolvable Microneedle Manufacturing Platform Technology: Two-Dose Thermostable IPV Patch

Robert Garcea of the University of Colorado Boulder in the U.S. will develop a method to manufacture ultrastable vaccines by coating them with nanoparticles so that multiple doses can be delivered in a single injection to reduce the costs associated with repeat immunizations and vaccine refrigeration. They have developed a method to heat-stabilize vaccines for transport and storage that involves controlled freeze-drying of antigens with adjuvants embedded in glassy organic matrices. This mixture is then coated with defined atomic layers of aluminum and additional antigens to protect the vaccines and control the release of the primer and booster vaccine at different times. They will further develop these methods to produce single-shot formulations of selected viral antigens for release at defined times and test their stability and ability to trigger a protective immune response in mice.

Robert Garcea of the University of Colorado Boulder in the U.S. will develop a method to manufacture ultrastable vaccines by coating them with nanoparticles so that multiple doses can be delivered in a single injection to reduce the costs associated with repeat immunizations and vaccine refrigeration. They have developed a method to heat-stabilize vaccines for transport and storage that involves controlled freeze-drying of antigens with adjuvants embedded in glassy organic matrices. This mixture is then coated with defined atomic layers of aluminum and additional antigens to protect the vaccines and control the release of the primer and booster vaccine at different times. They will further develop these methods to produce single-shot formulations of selected viral antigens for release at defined times and test their stability and ability to trigger a protective immune response in mice.

A Single-Administration Prime-Boost Vaccination Platform

Sebastian Ulbert of the Fraunhofer Institute for Cell Therapy and Immunology in Germany will develop a simple and safer method to inactivate viruses to reduce the cost of vaccine production. Currently the production of inactivated viral vaccines requires treating the viruses over several weeks with toxic chemicals which then need removing. This procedure is time-consuming, hazardous and costly and reduces vaccine activity. They have developed a low energy electron irradiation method that more safely and rapidly inactivates the pathogens by damaging only nucleic acids while leaving intact the protein antigens that trigger the desired protective immune response. They will adapt their approach for the production of a poliovirus vaccine and test different techniques and protocols for scaling up the technology to commercial vaccine production.

Sebastian Ulbert of the Fraunhofer Institute for Cell Therapy and Immunology in Germany will develop a simple and safer method to inactivate viruses to reduce the cost of vaccine production. Currently  the production of inactivated viral vaccines requires treating the viruses over several weeks with toxic chemicals which then need removing. This procedure is time-consuming, hazardous and costly and reduces vaccine activity. They have developed a low energy electron irradiation method that more safely and rapidly inactivates the pathogens by damaging only nucleic acids while leaving intact the protein antigens that trigger the desired protective immune response. They will adapt their approach for the production of a poliovirus vaccine and test different techniques and protocols for scaling up the technology to commercial vaccine production.