5,readycircuit袋和管路组件无菌管道化生产平台;.PDFVIP

GE Healthcare GE Healthcare Data File 29-9606-44AA ReadyToProcess Data file 28-9159-86 AA Process chromatography ReadyCircuit™袋和管路组件: 无菌管道化生产平台 ÄKTAready system 作为GE Healthcare’s ReadyToProcess™(RT P)生产平台的 一部分，ReadyCircuit无菌管路组件简化和加速了生物制 品加工过程。对于生物制药公司、CMOs和新创立的生物 ÄKTA™ ready is a liquid chromatography system built for 公司，RT P生产平台能够加速工艺开发并且减少前期投 process scale-up and production for early clinical phases 资。显著提高的生产灵活性可以帮助用户开拓新的商业 (Fig 1). The system operates with ready-to-use, disposable 机会。 flow paths that are available separately in High and Low Flow Kits. As a benefit, the need for cleaning between 独特之处在于，ReadyCircuit无菌管路组件可以实现快速 products/batches is eliminated and no development and 装配，并减少了清洗和清洗验证成本。也缩短了不同生 validation of cleaning procedures is required. Replacing 产批次间准备和轮换的周期。 flow paths between projects is fast, and when used together with ReadyToProcess™ columns, the risk for cross- 使用ReadyCircuit无菌管路组件，新创立的公司可以快速 contamination is removed. 和方便地开始产品研发活动，显著降低生产设备的大量 The ÄKTAready system is biocompatible and hygienic, 投入。 and meets all GLP and cGMP demands for Phase I–III in drug development and full-scale production. ÄKTAready ReadyCircuit快速无菌生产平台的优点 is controlled by UNICORN™ software, including a complete • 快速选型并灵活装配各种系列的无菌单元操作平台， guide and documentation for installation of Flow Kits and 用于生物样品的生产纯化 columns. • 整个无菌管路组件为一次性使用，用后即丢弃，避免 ÄKTAready system provides the following benefits: 清洗操作和清洗验证成本 • 前期可以快速进行工艺开发，而无需大量生产设备投资 the need for system cleaning including method development and validation 通用性 图1. 装配好的典型ReadyToProcess无菌管道化系统：包括 ReadyToProcess过滤膜，Readymates和管路组件。 通用性是ReadyCircuit家族的特点，使您能够设计和建立 procedures, and low downtime between products/ 你所能想象的几乎所有的无菌管道化的生物样品单元操 Fig 1. ÄKTAready is a chromat