Texas A&M dedicates national pandemic influenza vaccine manufacturing facility, on track for 2016 start-up phase
Texas Governor Rick Perry, Texas A&M University System Chancellor John Sharp, Texas A&M Health Science Center CEO Brett Giroir, M.D., and officials from the U.S. Department of Health and Human Services (HHS), State of Texas and biopharmaceutical company GSK today dedicated a national pandemic influenza vaccine manufacturing facility in Bryan, Texas, which when complete will serve as an anchor for the Texas A&M Biocorridor – a rapidly evolving hub of economic development and scientific discovery that is swiftly positioning Texas as the third coast in biotechnology.
Construction of the 100,000-square-foot facility is on track for completion by the end of 2015, to be followed by start-up and validation phases that are expected to be complete by early 2017. When fully functional, the facility is expected to have the capacity to produce the bulk antigen needed for up to 50 million adjuvanted pandemic influenza vaccine doses within four months of a declared influenza pandemic and availability of acceptable virus seeds.
“This facility represents a huge step forward for the State of Texas, and an important milestone in the United States’ battle against both contagious diseases and the specter of international bioterrorism,” Gov. Perry said. “Our state has long been home to innovative minds willing to attempt giant leaps to great achievement, and this will serve as another instance where Texans are willing to lead the way to a safer and more prosperous future.”
The Pandemic Influenza Vaccine Facility and the adjacent Viral-based Vaccine Facility, which recently entered final design development, will form the cornerstone of the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM), one of three such national centers for innovation supported by the U.S. Department of Health and Human Services and the only one housed at an academic institution.
“Texas A&M has a long and proud tradition of dedicated service to our nation,” Sharp said. “This facility, and the Texas A&M CIADM in which it is housed, builds upon that tradition and helps put Texas A&M at the forefront of translational research and development so that research discoveries will advance to the field faster to save lives.”
Disease outbreaks, such as the H5N1 avian influenza, H1N1 influenza pandemic of 2009, and more recently the Ebola outbreak in West Africa, exposed the need for quick access to high-quality, life-saving vaccines and therapeutics, and the importance of reliable, U.S.-based vaccine development and manufacturing capabilities and expertise. After the President’s Council of Advisors on Science and Technology report on reengineering the influenza vaccine manufacturing enterprise and the U.S. Department of Health & Human Services’ medical countermeasures review, HHS’ Biomedical Advanced Research and Development Authority (BARDA) embarked on new approaches to bolster pandemic influenza preparedness and biodefense.
The Texas A&M Center for Innovation in Advanced Development and Manufacturing was founded on a $285 million public-private partnership between HHS, and collaborating academic, commercial, and State of Texas stakeholders. Key objectives include performing advanced research and development, ensuring domestic manufacturing capacity, enabling FDA approval of products, and mentoring the next generation of public health professionals through education, training and outreach.
“This center is important for our nation, but also evidences a new paradigm for how academic health science centers must transform health by forging novel partnerships with the federal government and leveraging the expertise of world-leading commercial partners, such as GSK” Giroir said. “Texas A&M Health Science Center will continue to pioneer new pathways forward – this is the only way that unmet medical needs, locally and globally, will be addressed, and access to quality care can be achieved for all.”
With the Texas A&M CIADM’s advancement of the Pandemic Influenza Vaccine Facility and the Viral-based Vaccine Facility – along with the recent retrofit completion of the Texas A&M National Center for Therapeutics Manufacturing, which offers flexible and adaptable biopharmaceutical development and manufacturing capabilities – the center is on track to meet its mission of bolstering the nation’s preparedness and response to public health threats, whether in the form of a naturally occurring emerging infectious diseases or a biological terrorist attack.