Biomanufacturing at epi(demi)c proportions

By Kathryn Brink
Graduate Student, Systems, Synthetic and Physical Biology Program, Rice University

The COVID-19 virus has reached all inhabited continents and, as of March 17, has infected nearly 180,000 people. With more than 7,000 individuals already dead from the disease, the public is eagerly waiting for a vaccine. However, experts predict that we are at least a year away from a vaccine becoming widely available, and even after vaccine candidates are identified, it could take a year for pharmaceutical companies to scale up production to the billions of doses that will be required to curb the epidemic. Like many medicines, vaccines are typically produced using biomanufacturing — a process that uses cells or other biological systems as “miniature factories” to make complex biomolecules. However, the U.S. does not adequately fund biomanufacturing research and development; instead this funding is driven by the short-term, profit-driven decisions of the biotechnology industry. In the face of global disease outbreaks, the U.S. should promote and invest in developing a more innovative and adaptable biomanufacturing infrastructure that will enable the production of vaccines and drugs quickly when crises strike.

Manufacturing delays in vaccine development are nothing new. During the H1N1 “swine flu” epidemic in 2009, an effective vaccine was not available in most countries until after the peak of the epidemic had passed. Like the majority of seasonal influenza vaccines, the predominant H1N1 vaccine was developed and manufactured in chicken eggs, employing the same basic production strategy that has been in use for the past 50 years. Egg-based vaccine production is slow. It takes two weeks to produce a flu vaccine from a single batch of eggs, and it relies on huge quantities of eggs that take time for farmers (and their hens) to produce. While alternative approaches exist, many of them are more expensive (which would increase the cost of the vaccine) and still require time-consuming optimization steps. Even for the technologies that require the least amount of optimization, the U.S. vaccine industry lacks the infrastructure to produce non-egg-based vaccines quickly at the massive scale required for global distribution.

Strengthening and modernizing our biomanufacturing infrastructure could also help to address a second public health risk associated with the epidemic: drug shortages. According to the U.S. Food and Drug Administration, we are already experiencing a shortage of one (undisclosed) drug due to the COVID-19 outbreak, and we may experience more as quarantines continue to disrupt the global supply chain. China is a major supplier of drugs and drug ingredients, including up to 80% of raw ingredients used in antibiotic production, many of which are produced using biomanufacturing. A fast, adaptable biomanufacturing infrastructure in the United States will enable the biotechnology industry to ramp up the production of drugs and drug ingredients quickly in response to global shortages, whether caused by emerging diseases like the coronavirus or by political disputes with foreign trading partners.

As we have already begun to see, without timely access to vaccines, epidemics can cause major disruptions to public health and to the global economy. To prevent and mitigate these disruptions in the future, the U.S. should work with international partners to 1) invest in research and development of new or existing biomanufacturing processes; 2) facilitate academic-industry partnerships to develop innovative methods for scaling up the production of biotechnologies; and 3) incentivize companies to invest in an adaptable biomanufacturing infrastructure that can generate these products quickly and at scale. These efforts cannot just be reactive — a long-term investment strategy is needed so that researchers and the pharmaceutical industry are primed to respond to new diseases as they arise. Without this investment, we continue to leave ourselves unprepared and vulnerable in the face of emerging epidemics.

This blog post is part of the Baker Institute Science and Technology Policy Program’s Developing Civic Scientist Leaders project.