Photo of vaccines being prepared in the lab.

In the wake of recent disease outbreaks, the need for quick access to high-quality, life-saving vaccines shines light on the importance of reliable, U.S.-based vaccine manufacturing efforts.

Vaccines are among the greatest achievements in the history of public health. However, past challenges with vaccine development processes and frequent shortages during times of need have highlighted the importance of more extensive and reliable manufacturing operations. The 2009 H1N1 influenza pandemic brought to light some key areas in need of improvement on a national scale: dated, slow vaccine technology and too much reliance on foreign factories. 

As H1N1 reached a peak in June 2009 withall 50 states in the United States, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands reporting cases of infection, the federal government began putting into place a plan to more effectively address the need for highly flexible and adaptive domestic manufacturing technologies The results? Launch of three government-funded biodefense centers aimed at building the national medical countermeasure stockpile in the U.S. to stand ready with a near-immediate response to the next national public health threat, whether naturally occurring or a deliberate attack.

Founded on an initial $285.6 million public-private investment from the U.S. Department of Health and Human Services (HHS), including $176.6 million from the U.S. government and the remainder cost-shared by commercial and academic partners as well as the State of Texas, the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM) is one such center – and the only one housed within an academic institution – designed to develop vaccines, biologics and therapeutics much more rapidly, efficiently and cost-effectively than ever before. As a public-private partnership, the center leverages the expertise of a renowned research university and health science center, innovation of emerging biotechnology firms, and the development and manufacturing capabilities of global pharmaceutical companies.

“The three national centers are the first major U.S. domestic infrastructure to address biodefense threats and pandemic influenza,” said Gerald Parker, D.V.M., Ph.D., M.S., vice president for public health preparedness and response at the Texas A&M Health Science Center and principal investigator of the Texas A&M CIADM. “Their development represents a major step forward in ensuring our ability to protect the health of Americans when our nation faces imminent threats.”

Photo of Texas A&M CIADM's revolutionary facility.

Mobile clean rooms allow for development and simultaneous production of millions of doses of medical countermeasures against some of the world’s deadliest threats.

The center’s technology is founded on a 150,000-square-foot revolutionary facility that has pioneered highly flexible, adaptable mobile manufacturing platforms, at a capital cost 80 percent less than the current approach.

Mobile clean rooms – standalone, modular, biopharmaceutical “pods” – within the facility allow for development and simultaneous production of millions of doses of medical countermeasures against some of the world’s deadliest threats. These mobile clean rooms can be configured to support manufacture of vaccines against pandemic influenza or antidotes to biological, chemical or radioactive agents. Each room can be unplugged, pushed across the warehouse, and connected to a new production line — ready in days to make a different life-saving product as compared to the months that previous processes required.

Once the center is fully operational, the facilities will have the capability to supply fifty million vaccine doses within four months of receipt of a pandemic influenza strain, with first doses available in 12 weeks. This is twice as fast as the vaccine response to the H1N1 outbreak in 2009.

Unlike traditional influenza vaccines, grown in fertilized chicken eggs, the Texas A&M CIADM will produce the vaccines in animal cells, a cleaner and quicker process that also eliminates many of the allergic risks associated with egg-based vaccines. In fact, the center is expected to produce as many influenza vaccine doses in a single month as a traditional lab does in one year, at a fraction of the cost.

In addition to revolutionary influenza vaccine manufacturing, the Texas A&M CIADM is also refining advanced manufacturing techniques for all vaccine and medical countermeasures against biological and chemical threats, such as second generation anthrax vaccines, antibody therapies and treatments for radiation poisoning, which will serve as a national response platform for new naturally emerging infectious diseases like SARS and West Nile Virus. The goal is to speed response to public health threats before impending situations reach pandemic proportions.

“We need to be prepared for all hazards, not just the last one that hit us,” Parker said. “Other threats could emerge, such as the coronavirus behind Middle East respiratory syndrome, which surfaced in Saudi Arabia in 2012, or the Ebola virus outbreak currently devastating West Africa. If one of these viruses begins to spread and a vaccine can be developed, the center will need to produce it quickly and prepare it for the market at speeds never before seen.”

Ultimately, efforts at Texas A&M will have profound implications for the entire pharmaceutical industry, and most importantly for patients in need of life-saving new therapies.

“The threat of bioterrorism is very real and something we as a nation need to be prepared to face so that we can mitigate potential damage and save lives,” Parker said. “As a leading academic institution with a history of dedicated national service, Texas A&M is highly motivated to support vaccine and medical countermeasure development, manufacturing, licensure and delivery to populations in need.It may sound odd to think that the nation’s future can be found in a warehouse in College Station, Texas, but that is the case, and we stand ready.”

— Holly Shive

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