Abstract
A workshop was held at the 6th 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 towards 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 inform future industry-wide initiatives and prioritization of resources to achieve more flexible manufacturing.
- FDA Center for Drug Evaluation and Research
- biopharmaceutical process development
- biotechnology products
- innovation
- public private partnerships
- Received January 2, 2020.
- Accepted June 6, 2020.
- Copyright © 2020, Parenteral Drug Association
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