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通过在灵活的 J.POD® 设施中进行连续处理来降低生物制药制造成本。

Reducing biopharmaceutical manufacturing costs through continuous processing in a flexible J.POD® facility.

机构信息

Just-Evotec Biologics, Inc., 401 Terry Avenue North, Seattle, WA 98109, USA.

Just-Evotec Biologics, Inc., 401 Terry Avenue North, Seattle, WA 98109, USA.

出版信息

Drug Discov Today. 2023 Jul;28(7):103619. doi: 10.1016/j.drudis.2023.103619. Epub 2023 May 16.

Abstract

In this work, process models were developed to capture the impact of biomanufacturing costs on a commercial scale and emphasize the way in which facility design and operation must balance meeting product demand while minimizing production costs. Using a scenario-based modeling approach, several facility design strategies were evaluated, including a traditional large stainless-steel facility and a small footprint, portable-on-demand (POD)-based facility. Bioprocessing platforms were compared by estimating their total production costs across different facility types and specifically illustrating how continuous bioprocessing has gained in popularity as a novel and cost-effective approach to manufacture high-quality biopharmaceuticals. The analysis showed how fluctuations in market demand have a dramatic effect on manufacturing costs and plant utilization, with far-reaching implications on the total cost to patients.

摘要

在这项工作中,开发了过程模型来捕捉生物制造成本对商业规模的影响,并强调了设施设计和运营必须在满足产品需求的同时最小化生产成本的方式。使用基于场景的建模方法,评估了几种设施设计策略,包括传统的大型不锈钢设施和小型、按需便携(POD)设施。通过估计不同设施类型的总生产成本,并特别说明连续生物处理如何作为一种新颖且具有成本效益的方法来制造高质量生物制药而变得越来越受欢迎,对生物处理平台进行了比较。分析表明,市场需求的波动对制造成本和工厂利用率有巨大影响,对患者的总成本有深远影响。

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