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A BTEC success story: The BARDA influenza vaccine manufacturing training program

Q: Where do influenza vaccine manufacturers around the world get needed training?
A: BTEC

Over 5 years, 144 participants from 14 countries participated in 1 (or more) of 4 customized courses at BTEC as part of BARDA's Intermediate & Advanced Biomanufacturing Training program. BARDA funded the 1,240 hours of training BTEC provided with a grant of more than $3.5 million.

Program goal

To mitigate the global shortage of influenza vaccine and increase global pandemic preparedness by developing well qualified, technically proficient industry professionals

Sponsors

  • BARDA – Biomedical Advanced Research and Development Authority
  • WHO – World Health Organization
map indicating countries that participated in the BARDA program.

In 2009–2010, the H1N1 influenza A pandemic posed a global public health threat. In the United States, approximately 60 million cases of the flu occurred and caused more than 12,000 deaths and 270,000 hospitalizations, according to the Centers for Disease Control and Prevention. Shortly afterward, BTEC began a $3.5-million, five-year program that provided training to selected employees of influenza vaccine manufacturers from around the world. The training program, designed to build vaccine production capacity in developing countries, was funded by annual grants from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.

If a widespread outbreak of influenza were to occur, increased manufacturing capacity would help meet the demand for the vaccine. “In the event of a pandemic, manufacturers across the globe will be expected to rapidly produce vaccines to save lives,” BTEC Director Ruben Carbonell said. “This training increases the world's infrastructure for safe vaccines and, by extension, helps protect the United States from pathogens borne by air or other sources.”

To deliver the program, which ran from 2011–2105, an interdisciplinary team headed by BTEC personnel designed and developed four different multi-week courses, brought trainees to the NC State campus, and provided the classroom and hands-on laboratory training in BTEC's facilities. A total of 144 trainees from 14 countries participated in one or more of the courses developed specifically for the program. Participants came from biopharmaceutical manufacturing institutions in Brazil, China, Egypt, India, Indonesia, Kazakhstan, Mexico, Romania, Russia, Serbia, South Africa, South Korea, Thailand, and Vietnam.

Courses were taught by an interdisciplinary team of experts from BTEC, NC State's College of Agriculture and Life Sciences, Duke University, and industry. The university's Global Training Initiative, which partnered with BTEC to deliver the program, assisted by arranging travel, lodging, local transportation, and cultural activities for participants.

The Fundamentals of cGMP Influenza Vaccine Manufacturing course focused on routine operations for the production of influenza vaccine and the regulations that govern manufacturing. Two advanced courses, Advanced Upstream Processes for Influenza Vaccine Manufacturing and Advanced Downstream Processes for Influenza Vaccine Manufacturing, taught students how to design new or optimize existing processes for vaccine production. Beginning in 2013, a special version of the Fundamentals course was offered for representatives of regulatory agencies; this course was supported by both BARDA and the World Health Organization.

Throughout the program, participants' comments on end-of-course evaluations were exceedingly positive. Follow-up surveys showed the information provided at BTEC was relevant to on-the-job activities and was disseminated to others in the various organizations. The five-year project concluded successfully at the end of the U.S. government's 2015 fiscal year.