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Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development
Kelvin H Lee1, Jennifer L Mantle1
1National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE 19713.
PDA Journal of Pharmaceutical Science and Technology
|June 17, 2020
Summary
Biopharmaceutical leaders identified technological barriers and opportunities for flexible manufacturing. Advancements in analytical technologies and upstream operations are key to achieving high-throughput, adaptable biomanufacturing processes.
Area of Science:
- Biopharmaceutical Manufacturing
- Process Development
- Technology Innovation
Background:
- Industry leaders convened to address challenges in biopharmaceutical manufacturing.
- The biopharmaceutical industry is shifting towards more flexible and high-throughput manufacturing states.
Purpose of the Study:
- To identify technological barriers hindering flexible biopharmaceutical manufacturing.
- To explore technology opportunities and business drivers for advanced manufacturing.
Main Methods:
- An anonymous pre-meeting survey assessed technological barriers.
- Live polling and expert discussions were used during the workshop.
- Senior industry leaders participated in the discussions.
Main Results:
- New analytical technologies and upstream operations were identified as key opportunities.
- Speed, simplicity, flexibility, and the global regulatory environment are major business drivers.
- Industry-wide needs and concerns regarding flexible manufacturing were identified.
Conclusions:
- Technological advancements in analytics and upstream processes are crucial for flexible manufacturing.
- Business drivers and regulatory factors significantly impact the adoption of flexible manufacturing.
- The workshop identified actionable insights for future industry initiatives and resource prioritization.
Keywords:
Biopharmaceutical process developmentBiotechnology productsFDA Center for Drug Evaluation and ResearchInnovationPublic private partnershipsMore Related Videos
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