生物产品下游加工的现状和未来发展:从复苏的前景XIX产生圆桌讨论
Alois Jungbauer1, Gisela Ferreira2, Michelle Butler3
1Department of Biotechnology, Institute of Bioprocess Science and Engineering, University of Natural Resources and Life Sciences, Vienna, Austria.
Biotechnology and bioengineering
|May 25, 2024
概括
快速开发COVID-19疫苗是一项非凡的壮举,对于正常的药物开发来说是不可持续的. 确保患者在全球范围内获得药品需要平衡速度与安全性,并应对复杂的制造挑战.
科学领域:
- 生物制药制造业 生物制药制造业
- 药物开发 药物开发
- 全球健康 全球健康
背景情况:
- 由于COVID-19大流行,疫苗研发需要前所未有的速度,包括全球合作和先进的决策模型.
- 这种加快的努力虽然在疫苗方面取得了成功,但可能会将其他关键药物开发管道排除在外.
- 确保持续的药物供应和患者获取,尤其是在低收入和中等收入国家,仍然是一个重大挑战.
研究的目的:
- 分析生物制药行业对大流行病的反应及其对未来药物开发和患者获取的影响.
- 讨论与制药制造相关的复杂性和成本,包括基础设施和工艺开发.
- 探索治疗方式的演变和采用新制造技术的发展.
主要方法:
- 审查流行病应对策略,包括沟通,决策模型和疫苗开发的全球物流.
- 对生物制药制造成本的分析,重点关注药物发现,工艺开发和基础设施.
- 检查新兴的治疗形式和先进的制造技术,如连续生物制造.
主要成果:
- 疫情驱动的疫苗开发速度是不可持续的,以牺牲其他治疗领域为代价.
- 药物制造存在重大复杂性,需要在发现,开发和基础设施方面进行大量投资.
- 新的治疗方式和先进的制造技术,如平台工艺和连续生物制造,对于未来的效率至关重要.
结论:
- 对于所有药物来说,将10年的开发时间缩短到1年的时间是不可行的.
- 在制药行业中,平衡速度,成本,安全性和全球患者获取权至关重要.
- 可持续的下游加工和采用基于模型的战略对于生物制药制造业的未来至关重要.
相关概念视频
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01:27Upstream Processing
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01:14Scale-Up Processes
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01:22Bioreactor Controls-III
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01:30Production of Pharmaceuticals
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01:23Vaccine Production
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