BTEC has a successful track record of working with federal agencies to provide specialized training programs in biomanufacturing. Of particular note are its ongoing training program with the U.S. Food and Drug Administration (FDA) and a five-year program completed for the Biomedical Advanced Research and Development Authority (BARDA).
10th FDA ORA online/on-site training program class is underway
Each fall since 2008, a new cohort of personnel from the U.S. FDA begins a series of four training courses that BTEC provides to the agency on a contract basis. The tenth group started the program in fall 2016, bringing the total number of FDA participants in this successful program to almost 150. Under the terms of a contract with the Office of Regulatory Affairs, a maximum of 15 pharmaceutical/biopharmaceutical inspectors and field personnel—primarily consumer safety officers, scientists, drug specialists, and investigators—participate in these courses each year. Each of the four courses in the program begins with a four-week online component and concludes with several days of intensive hands-on training at the BTEC facility. Online instruction focuses on the conceptual and theoretical knowledge associated with the course topics, while on-site instructional activities are largely experiential and take place throughout the BTEC facility. The courses—Upstream Bioprocessing, Downstream Bioprocessing, Quality Control/Analytical, and Fill/Finish—enable FDA investigators to gain an increased understanding of key biomanufacturing principles and processes. More information »
New training program for FDA CDER begins summer 2017
Beginning in July 2017, BTEC will provide a series of three courses to personnel from the FDA's Center for Drug Evaluation and Research (CDER). Similar to the training program for personnel from the FDA's Office of Regulatory Affairs (see story above), a group of 12 professionals from CDER will complete three blended (part online/part on site) courses during 2017–2018. More information »
Q: Where do influenza vaccine manufacturers around the world get needed training?
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.
To mitigate the global shortage of influenza vaccine and increase global pandemic preparedness by developing well qualified, technically proficient industry professionals
- BARDA – Biomedical Advanced Research and Development Authority
- WHO – World Health Organization
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.
Note: Courses provided under contracts and grants are not open to the public.