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Vaccine production training to develop the workforce of foreign institutions supported by the BARDA influenza vaccine capacity building program

机译:疫苗生产培训,以在BARDA流感疫苗能力建设计划的支持下培养外国机构的劳动力

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In the event of an influenza pandemic, vaccination will be the best method to limit virus spread. However, lack of vaccine biomanufacturing capacity means there will not be enough vaccine for the world's population. The U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) provides support to the World Health Organization to enhance global vaccine production capacity in developing countries. However, developing a trained workforce in some of those countries is necessary. Biomanufacturing is labor-intensive, requiring unique skills not found in traditional academic programs. Employees must understand the scientific basis of biotechnology, operate specialized equipment, and work in an environment regulated by good manufacturing practices (cGMP). Therefore, BARDA supported development of vaccine biomanufacturing training at Utah State University. The training consisted of a three-week industry-focused course for participants from institutions supported by the BARDA and WHO influenza vaccine production capacity building program. The curriculum was divided into six components: (1) biosafety, (2) cell culture and growth of cells in bioreactors, (3) virus assays and inactivation, (4) scale-up strategies, (5) downstream processing, and (6) egg- and cell-based vaccine production and cGMP. Lectures were combined with laboratory exercises to provide a balance of theory and hands-on training. The initial course included sixteen participants from seven countries including: Egypt, Romania, Russia, Serbia, South Korea, Thailand, and Vietnam. The participant's job responsibilities included: Production, Quality Control, Quality Assurance, and Research; and their education ranged from bachelors to doctoral level. Internal course evaluations utilized descriptive methods including surveys, observation of laboratory activities, and interviews with participants. Generally, participants had appropriate academic backgrounds, but lacked expertise in vaccine production. All participants acknowledged the utility of the training, and many expressed interest in receiving additional support to implement new practices at their home institutions
机译:如果发生流感大流行,接种疫苗将是限制病毒传播的最佳方法。但是,缺乏疫苗的生物制造能力意味着世界上没有足够的疫苗。美国卫生与公共服务部生物医学高级研究与开发局(BARDA)向世界卫生组织提供支持,以提高发展中国家的全球疫苗生产能力。但是,有必要在其中一些国家培养训练有素的劳动力。生物制造是劳动密集型的,需要传统学术课程中没有的独特技能。员工必须了解生物技术的科学基础,操作专用设备,并在良好生产规范(cGMP)规定的环境中工作。因此,BARDA支持在犹他州立大学开发疫苗生物制造培训。培训包括为期三周的针对行业的课程,面向受到BARDA和WHO流感疫苗生产能力建设计划支持的机构的参与者。该课程分为六个部分:(1)生物安全性;(2)生物反应器中的细胞培养和细胞生长;(3)病毒测定和灭活;(4)扩大规模的策略;(5)下游加工;以及(6) )基于卵和细胞的疫苗生产和cGMP。讲座与实验室练习相结合,以提供理论与实践培训之间的平衡。初始课程包括来自七个国家的16名参与者:埃及,罗马尼亚,俄罗斯,塞尔维亚,韩国,泰国和越南。参与者的工作职责包括:生产,质量控制,质量保证和研究;他们的教育程度从学士学位到博士学位。内部课程评估使用描述性方法,包括调查,观察实验室活动以及与参与者进行访谈。通常,参与者具有适当的学术背景,但是缺乏疫苗生产方面的专业知识。所有参与者都承认培训的实用性,许多参与者表示有兴趣获得更多支持,以在其本国机构实施新做法

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