The Golden LEAF Biomanufacturing Training and Education Center (BTEC), North Carolina State University, Raleigh, North Carolina, USA.
Department of Civil, Chemical, Environmental, and Materials Engineering, Alma Mater Studiorum, University of Bologna, Bologna, Italy.
Hum Gene Ther. 2023 Apr;34(7-8):259-272. doi: 10.1089/hum.2022.235.
The manufacturing of gene therapy products is a rapidly growing industry bolstered by the tremendous potential of these therapies to provide lifesaving treatment for rare and complex genetic diseases. The industry's steep rise has resulted in a high demand for skilled staff required to manufacture gene therapy products of the expected high quality. To address this skill shortage, more opportunities for education and training in all aspects of gene therapy manufacturing are needed. The Biomanufacturing Training and Education Center (BTEC) at the North Carolina State University (NC State) has developed and delivered (and continues to deliver) a 4-day, hands-on course titled Hands-on cGMP Biomanufacturing of Vectors for Gene Therapy. The course, which consists of 60% hands-on laboratory activities and 40% lectures, aims to provide a comprehensive understanding of the gene therapy production process, from vial thaw through the final formulation step, and analytical testing. This article discusses the design of the course, the backgrounds of the nearly 80 students who have participated in the seven offerings held since March 2019, and feedback from the course participants.
基因治疗产品的制造是一个快速发展的行业,这些疗法具有为罕见和复杂的遗传性疾病提供救生治疗的巨大潜力。该行业的迅猛发展导致对制造预期高质量基因治疗产品所需的熟练员工的需求很高。为了解决这种技能短缺问题,需要在基因治疗制造的各个方面提供更多的教育和培训机会。北卡罗来纳州立大学(NC State)的生物制造培训和教育中心(BTEC)已经开发并提供(并将继续提供)为期 4 天的动手课程,名为“基因治疗用载体的 cGMP 实操生物制造”。该课程由 60%的实操实验室活动和 40%的讲座组成,旨在全面了解基因治疗生产过程,从小瓶解冻到最终配方步骤和分析测试。本文讨论了课程的设计、自 2019 年 3 月以来参加过七次课程的近 80 名学生的背景,以及课程参与者的反馈。
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