SolaVAX: Rapid Development of a Vaccine for COVID-19
Available for Licensing, Collaboration, and Funding
US Utility Patent Pending (Not Yet Published)
Raymond P. Goodrich
Richard A. Bowen
At A Glance
Researchers at Colorado State University are developing an inactivated virus vaccine for COVID-19 (SolaVAX™) repurposing an existing technology platform for the inactivation of pathogens in blood product. The technology of whole virus inactivation utilizes a unique property of Riboflavin and UV light to selectively inactivate virus particles by directed damage to nucleic acids while preserving the integrity of the proteins and viral antigens.
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Development of any vaccine requires attenuation of virus itself, usually by chemical means. Many of these agents pose handling concerns, such as toxicity (all are carcinogens) and explosion hazards (ex: ethyleneimine). As such, these hazards have driven many groups to consider alternative ways to make vaccines that avoid them. Additionally, many sites cannot perform these processes, as they do not have the containment facilities required to handle the chemicals. Thus, the number of facilities that could readily assist in the vaccine production pipeline in a time of crisis is limited globally.
An endogenous photosensitizer developed for the inactivation of pathogens in blood products can be utilized to catalyze specific DNA and RNA chemistry with viral, bacterial or cellular agents may subsequently be used in vaccine preparations. While extensive toxicology studies and commercialized application of this technology platform have occurred since 2007, close to 1 million patients have since been treated with various blood products. The platform is now used broadly on a global basis in blood treatment centers.
The platform has been shown to inactivate MERS-CoV, another virus in the Coronavirus family, very efficiently and has also been evaluated for production of vaccine products using adeno-associated and Lentivirus constructs.
Researchers at Colorado State University intend to utilize this platform with stock virus cultures grown in the CSU’s BioMARC BSL-3 facility, a cGMP compliant manufacturing facility operated by the University on a non-profit basis. BioMARC has the capability and capacity to produce large quantities of viruses, perform inactivation procedures and operates BSL-3 labs for high containment biological manufacturing operations. This facility was established as a Regional Center of Excellence and currently operates as part of the Regional Biocontainment/National Biocontainment laboratory network under NIAID.
Studies in animal models are being conducted at Colorado State University in a BSL-3 facility capable of housing both large and small animal models under high containment conditions. The two principal investigators for this program (Dr. Raymond P. Goodrich and Dr. Richard Bowen) have extensive experience in working with virus inactivation, animal model studies of infectious disease, and vaccine preparation and evaluation methods. Both have faculty appointments at Colorado State University where Dr. Goodrich is responsible for the management of the Infectious Disease Research Center.
Equipment, disposables and reagents utilized in the process are already available in commercial forms and are used in routine in settings outside of the US under a CE Mark. Additionally, these components are currently being utilized in clinical studies in The United States under an Investigational Device Exemption from the FDA (clinicaltrials.gov identifier NCT02964325).
Figure 1: SARS-CoV-2 Reduction/Inactivation Data
(Figure 1) The inactivation run was performed in the Mirasol device (Terumo BCT, Lakewood, CO) using 100 mLs of solution spiked with 4E+06 virus per mL (6.6 Log virus/ mL). This yielded a final tier of virus of about 5.2 Log virus per mL. The container utilized for treatment is a standard Mirasol PRT illumination bag (citrate plasticized PVC, 1 Liter volume, Terumo BCT, Lakewood, CO). The limit of detection for this is 1.0 Log per mL, which means > 4.2 Log Reduction. Energy dose utilized is measured on the device with a calibrated optical meter. A dose of 100 Joules was delivered in 19 seconds. Complete inactivation was achieved at this timepoint, to the limit of detection.
- One device and a single bag (300 mLs) can produce up to 3 million doses of vaccine in less than 5 minutes
- Rapid and affordable production of the inactivated vaccine is both practical and cost-effective
- Throughput and cost calculations indicate that within 1 month, a sufficient amount of vaccine product can be manufactured for every person on the planet at a cost of less than $200K
- Photosensitizer provides for low toxicity and thus easy handling, distribution and processing under even austere conditions
- Platform has been shown to inactivate MERS-CoV, another virus in the Coronavirus family
- Technique has been previously evaluated for vaccine products
Last updated: April 2020