title: Comprehensive hands-on training for influenza vaccine manufacturing: a WHO-BARDA-BTEC partnership for global workforce development.
abstract: The critical need for enhancing influenza pandemic preparedness in many developing nations has led the World Health Organization (WHO) and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), to develop an international influenza vaccine capacity-building program. Among the critical limitations faced by many of these nations is lack of access to training programs for staff supporting operations within vaccine production facilities. With support from BARDA, the Biomanufacturing Training and Education Center (BTEC) at North Carolina State University has addressed this need for training by developing and delivering a comprehensive training program, consisting of three courses: Fundamentals of cGMP Influenza Vaccine Manufacturing, Advanced Upstream Processes for Influenza Vaccine Manufacturing, and Advanced Downstream Processes for Influenza Vaccine Manufacturing. The courses cover process design, transfer, and execution at manufacturing scale, quality systems, and regulations covering both manufacturing and approval of pandemic vaccines. The Fundamentals course focuses on the concepts, equipment, applicable regulations, and procedures commonly used to produce influenza vaccine. The two Advanced courses focus on process design, scale up, validation, and new technologies likely to improve efficiency of vaccine production. All three courses rely on a combination of classroom instruction and hands-on training in BTEC's various laboratories. Each course stands alone, and participants may take one or more of the three courses. Overall participant satisfaction with the courses has been high, and follow-up surveys show that participants actively transferred the knowledge they gained to the workplace. Future plans call for BTEC to continue offering the three courses and to create an online version of several modules of the Fundamentals course.
authors.affiliation: Golden LEAF Biomanufacturing Training and Education Center, College of Engineering, North Carolina State University, Raleigh, North Carolina, 27695-7928.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Ruiz
authors.forename: Gary L
authors.initials: GL
authors.lastname: Gilleskie
authors.forename: Patty
authors.initials: P
authors.lastname: Brown
authors.forename: Bruce
authors.initials: B
authors.lastname: Burnett
authors.forename: Ruben G
authors.initials: RG
authors.lastname: Carbonell
mesh_terms: D057191:Capacity Building / Q000379:methods*; D004496:Education, Continuing / Q000379:methods*; D006801:Humans; D007252:Influenza Vaccines / Q000096:biosynthesis / Q000276:immunology*; D020407:Internet; D016730:Program Development / Q000379:methods*; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000193:education / Q000379:methods*; D014481:United States; D014483:United States Dept. of Health and Human Services; D014944:World Health Organization
chemical_list: D007252:Influenza Vaccines
keywords: active learning; cGMP manufacturing; developing countries vaccine manufacturers; global vaccine capacity-building; influenza vaccine; workforce development