Lee Kelvin H, Mantle Jennifer L
National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE 19713.
PDA J Pharm Sci Technol. 2021 Jan-Feb;75(1):48-63. doi: 10.5731/pdajpst.2020.011429. Epub 2020 Jun 15.
A workshop was held at the 6 Accelerating Biopharmaceutical Development meeting in Carlsbad, CA on February 18, 2019. An anonymous survey was sent to all industry participants before the meeting to identify their top technological barriers to achieving a future manufacturing state and a real-time polling tool was used to collect live feedback during the meeting. Senior leaders from across the biopharmaceutical industry discussed the top technology opportunities to enable high-throughput, flexible manufacturing capabilities and business drivers for the industry. New analytical technologies and upstream operations were identified to be opportunities that could have a profound effect on the shift toward flexible manufacturing. Further discussion at the workshop also identified key business drivers, such as speed, simplicity, and flexibility, as well as the global regulatory environment, to be factors that have a major impact on an organization's ability to implement flexible manufacturing. This workshop has identified industry-wide needs and concerns and can inform future industry-wide initiatives and prioritization of resources to achieve more flexible manufacturing.
2019年2月18日，一场研讨会在加利福尼亚州卡尔斯巴德举行的第六届加速生物制药开发会议上召开。会议前，向所有行业参与者发送了一份匿名调查问卷，以确定他们在实现未来制造状态方面面临的首要技术障碍，并使用了实时投票工具在会议期间收集现场反馈。生物制药行业的高级领导人讨论了实现高通量、灵活制造能力的首要技术机遇以及该行业的商业驱动因素。新的分析技术和上游操作被确定为可能对向灵活制造转变产生深远影响的机遇。研讨会上的进一步讨论还确定，速度、简单性和灵活性等关键商业驱动因素以及全球监管环境是对组织实施灵活制造能力有重大影响的因素。本次研讨会确定了全行业的需求和关注点，并可为未来全行业的举措以及资源优先级提供参考，以实现更灵活的制造。
