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首页> 外文会议>Conference on single-use technologies II: bridging polymer science to biotechnology applications >THE NEVOLINE™ MANUFACTURING SYSTEM: INTENSIFICATION INTEGRATION OF UPSTREAM AND DOWNSTREAM PROCESSING IN A LOW-FOOTPRINT, AUTOMATED PLATFORM FOR VIRAL PRODUCTION
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THE NEVOLINE™ MANUFACTURING SYSTEM: INTENSIFICATION INTEGRATION OF UPSTREAM AND DOWNSTREAM PROCESSING IN A LOW-FOOTPRINT, AUTOMATED PLATFORM FOR VIRAL PRODUCTION

机译：NEVOLINE™制造系统：在低足迹，自动化生产病毒的平台上加强和整合上游和下游加工

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These guidelines have been prepared in the format that should be used for the abstract submission. Authors should replace the text of this template in order to prepare their abstracts. Fonts, sizes and spacing should be used as they are used in this document. Page size is US 8.5 inch × 11 inch, top and bottom margin 0.8 inches, left and right margin 0.8 inches. Body text should be written in Arial, 10 pt, single spacing. The Abstract, in English, should introduce the proposed paper's subject, summarize its contents, explain any unique aspects, and clearly indicate the specific relevance to the themes of the Conference. Do not sub-divide the text into separate sections. References may be included at the bottom. The world is facing an under-supply of some key vaccines due to poor synergies between growing market demands and aging production models. In this light, we have developed a proof of concept of a vaccine manufacturing platform aiming at increasing availability and affordability of vaccines - the NevoLineTM system. This simulated continuous and automated platform integrates both USP1 and DSP2 processes and is encapsulated into an isolator, making it a self-contained production unit (6m~2). The technology relies on a single-use, high-density fixed-bed bioreactor operated in perfusion chained with downstream filtration, clarification and polishing steps to (a) decrease batch time, (b) reduce equipment utilization, (c) optimize utilities consumption and (d) intensify operations. By optimizing single-use technologies we are able to drastically reduce CAPEX3, CoGs4 and footprint and increase production capacity. Such manufacturing platform can easily be implemented into flexible facilities with simplified infrastructure, increasing adaptability in production and capacity for record time-to-market. This study will present the platform proof of concept on Vero line and trivalent inactivated polio vaccine (sIPV) production, achieving low CoGs (0,28$/dose for a trivalent sIPV) and large capacity. The presentation will feature the description of engineering development, but also results of cell growth, infections and product quality, as well as a description of the CAPEX, CoGS and capacity calculations. This manufacturing platform is undergoing sIPV process scale-up and pre-clinical bulk production. The NevoLine system is expected to produce any type of viral vaccine at a very low cost and large capacities to face global health challenges.
机译：这些准则已经以摘要提交应使用的格式编写。作者应替换此模板的文本，以准备其摘要。应使用本文档中使用的字体，大小和间距。页面尺寸为美国8.5英寸×11英寸，上下边距为0.8英寸，左右边距为0.8英寸。正文应以Arial（10磅）单间距书写。摘要应以英文形式介绍拟议论文的主题，总结其内容，解释任何独特之处，并明确指出与大会主题的具体相关性。请勿将文本细分为单独的部分。引用可能包含在底部。由于不断增长的市场需求与老化的生产模式之间的协同作用较弱，因此世界上一些关键疫苗的供不应求。因此，我们开发了旨在提高疫苗的可用性和可负担性的疫苗生产平台的概念验证-NevoLineTM系统。这个模拟的连续和自动化平台集成了USP1和DSP2工艺，并封装在一个隔离器中，使其成为一个独立的生产单元（6m〜2）。该技术依赖于一次性使用的高密度固定床生物反应器，该生物反应器与下游的过滤，澄清和抛光步骤链接在一起进行灌流操作，以（a）减少批处理时间，（b）减少设备利用率，（c）优化公用事业消耗，以及（四）加大经营力度。通过优化一次性技术，我们能够大幅减少CAPEX3，CoGs4和占地面积，并提高生产能力。这样的制造平台可以轻松地在具有简化基础架构的灵活设施中实施，从而提高生产的适应性和创纪录的上市时间的能力。这项研究将提供有关Vero品系和三价灭活脊髓灰质炎疫苗（sIPV）生产的概念平台证明，可实现低CoG（三价sIPV每剂量0.28美元）和大容量。该演讲将介绍工程开发的描述，以及细胞生长，感染和产品质量的结果，以及CAPEX，CoGS和容量计算的描述。该制造平台正在进行sIPV工艺放大和临床前批量生产。 NevoLine系统有望以极低的成本和强大的能力生产任何类型的病毒疫苗，以应对全球健康挑战。

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