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首页> 外文会议>Conference on single-use technologies III >STERILE MEDIA HOLD SCALE-UP USING MOBIUS? SINGLE-USE TECHNOLOGY
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STERILE MEDIA HOLD SCALE-UP USING MOBIUS? SINGLE-USE TECHNOLOGY

机译：无菌介质使用Mobius举行扩展？单用技术

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The benefits of single-use systems (SUS) in biopharmaceutical manufacturing are well understood, and their use is widespread in the manufacture of mAb, rProteins, and related therapies. New frontiers in medicine such as cell and gene therapy present an opportunity for SUS to enable speed to the clinic, however some unique hurdles must be overcome. This poster outlines the collaborative development of a single-use process to address the challenge of supplying sterile media to a bioreactor for inoculation and growth of human tissue cells. To alleviate time constraints, cleaning concerns, and contamination risks, the biopharmaceutical manufacturer chose to employ single-use technology when conducting a 5-fold scale up from a glass bottle process. A significant challenge with this human tissue cell culture process is the 60-day sterile media hold at the cell culture temperature of 36°C, during which time the bioreactor is intermittently perfused with fresh media. The Mobius? Mix50 single-use mixer (SUM) solves this challenge by first beginning with a sterile, gamma-irradiated mixer bag to eliminate concerns over validation of CIP and SIP cycles. Next, a low-pressure overlay is maintained with a carefully-sized hydrophobic vent filter, to prevent contaminants from entering the sealed mixer container. Process variables requiring assessment for this application include the air overlay pressure and flow rate, the liquid (media) flow rate during filling and draining of the SUM, sizing of the vent filter area, the liquid volume in the SUM, and the sterile condensate collection rate. A series of experiments provided a repeatable and scalable single-use solution for implementation into the manufacturing process. This novel application demonstrates the flexibility of single-use in the rapidly expanding clinical market of products derived from human cells with the unique challenges they present.
机译：单用系统（SUS）在生物制药制造中的好处得到了很好的理解，它们的使用是在制造MAB，RPRECTEINS和相关疗法中的普及。诸如细胞和基因治疗等药物中的新边界介绍了苏为临床速度的机会，但必须克服一些独特的障碍。这张海报概述了一次使用过程的协同开发，以解决将无菌培养物提供给生物反应器的挑战，以接种和生长人类组织细胞。为了减轻时间限制，清洁问题和污染风险，生物制造商在从玻璃瓶工艺进行5倍的缩放时选择使用一次性技术。这种人体组织细胞培养方法的重大挑战是在36℃的细胞培养温度下保持60天的无菌培养基，在此期间生物反应器间歇性地与新鲜介质灌注。莫伊斯？ Mix50单用混合器（SUM）首先以无菌γ辐照的混合器袋开始解决这一挑战，以消除CIP和SIP循环的验证的疑虑。接下来，用仔细尺寸的疏水通气过滤器保持低压覆盖物，以防止污染物进入密封的混合器容器。需要评估用于该应用过程变量包括空气覆盖的压力和流速，液体（介质）填充和SUM的排放过程中流速，通风过滤器区域，在SUM的液体体积，并且所述无菌冷凝物收集的上浆速度。一系列实验提供了一种可重复和可扩展的单用解决方案，用于实施制造过程。这种新的应用表明，在从人类细胞的快速扩展临床市场中具有单一使用的灵活性，其存在的独特挑战。

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