Description of proposed project

The goal of our project is to create a new platform for faster production of whole-virus, recombinant and subunit vaccines against seasonal influenza virus and yellow fever virus. Each year, hundreds of millions of people are infected by these viruses, and hundreds of thousands of lives are lost due to the lack of efficient (influenza) or sufficient (yellow fever) vaccines. Whole-virus virus vaccine production involves culturing hundreds of thousands of liters of virus that is purified and vialed into vaccine doses. Currently, the virus stocks for these vaccines are grown in embryonated chicken eggs. This method is slow to scale (e.g., 1-3 eggs per seasonal influenza vaccine dose), and results in vaccines that have low efficacy due to avian adaptive mutations acquired by the viruses as they grow in eggs (e.g., variable yearly protection from seasonal flu vaccine). Furthermore, the vaccine supply is critically dependent on the supply of pathogen-free eggs which cannot easily ramp up during adverse events (it takes 1-3 eggs to make one influenza vaccine dose).

We have conceptualized a new way to produce very large vaccine stocks using engineered cell lines that avoids the problems associated with egg-based virus production. The advantage of our approach is that the cells can be expanded to huge volumes rapidly. All downstream processing steps to make the vaccine doses are identical to the egg-based approach, allowing the seamless integration of this technology into the existing vaccine supply chain. Furthermore, in addition to influenza and yellow fever viruses, our approach can be adapted to manufacture other existing live-attenuated or inactivated vaccines (chickenpox, rotavirus etc.) as well novel future vaccines. The cost of vaccine manufacturing will be reduced using our approach, as the cost of the eggs can be ~50% of the total cost per dose. Vaccine manufacturing capacity will also be increased as scale up of cells is far easier than that of eggs. The quality of the vaccines will greatly improve as no egg adaptive mutations will occur as they currently do. If successful, this project will create a new vaccine manufacturing platform for the production of a wide range of current and future vaccines.

Why are you qualified to work on this?

My team brings over 45 years of molecular biology and virology expertise, 8 years of regulatory experience and 25 years in business development. Team members have over 100 peer-reviewed publications, generated > 1500 gene and virus constructs and created > 50 unique cell lines.

Other links

Our company website is https://advancedvirology.com/.

What would you do if not funded?

We will delay starting the project until we self-fund from company operations or raise funds from additional sources.

How much money do you need?

$50,000 to $100,000. My company has an operational BSL-2 virology R&D and manufacturing lab. I will use this grant to purchase the lab reagents and supplies needed for this project. We will use the supplies to create the first iteration of the cell lines for influenza and yellow fever virus production. This will include engineering the cells, testing the cells for virus production levels and viral genome fidelity and testing the feasibility of expansion into very large, vaccine-scale volumes.