PreDictor™ plates为一次性使用的96孔滤板，预填充适量的BioProcess™层析介质。第一代板填充的为Capto™或MabSelect™介质。
PreDictor板可采用手动或自动的工作流程，对层析条件进行平行筛选，从而支持高通量的工艺开发（high-throughput process development HTPD）。PreDictor板可快速高效的评估样品与介质的结合/清洗/洗脱条件的相关参数，同时还可以评估介质基准。使用PreDictor板获得的数据与层析柱所得的数据具有很好的相关性，使得PreDictor板成为工艺操作条件初筛的极佳的工具。
使用PreDictor板和HTPD工作流程可以：
缩短临床报告的时间
省时省力地获得更多的工艺信息
减少样品消耗
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PreDictor plates for High-Throughput Process Development
PreDictor™ 96-well filter plates, Benefits of using PreDictor, Screening of loading conditions on Capto™ S using a new highthroughput format, High-throughput screening of elution conditions on Capto MMC using PreDictor plates.
PreDictor plates are disposable 96-well filter plates prefilled with GE Healthcare BioProcess™ chromatography media. PreDictor plates support high throughput process development (HTPD) by allowing parallel screening of chromatographic conditions. They can be used in automated workflows using robotic systems, or can be operated manually using multi-channel pipettes. Each well in a PreDictor plate is prefilled with a defined amount of chromatography medium.
High-throughput process development with PreDictor plates
Time-to-clinic and time-to-market are two key factors for successful biopharmaceutical development. Efficient development of the manufacturing process is a crucial component of the overall project plan. However, screening optimal process conditions can be time-consuming and tedious. In addition, steadily increasing demands from regulatory authorities for better understanding and control of manufacturing processes put even more pressure on development work. Employing high-throughput tools for process development helps address these challenges.
High-throughput process development (HTPD) shortens development time at the same time as it increases the amount of information available during early process development. Evaluating chromatographic conditions can be performed in parallel using 96-well filter plates. As a result, a large number of experimental conditions can be evaluated simultaneously. This allows a large experimental space to be characterized and supports the definition of a well-established process design space where process parameters that need to be monitored and controlled are understood .
This handbook focuses on process development work in PreDictor™ 96-well filter plates, which are prefilled with chromatography media (resins). The handbook describes how results obtained using PreDictor plates can be used to define process conditions for large-scale chromatography. Applications of PreDictor plates are provided, as well as practical hints and tips. Assist software, dedicated to allow high-throughput methodology using PreDictor plates, is also described.
PreDictor™ 96-well filter plates and Assist software
Using PreDictor plates and Assist software shortens time-toclinic and increases productivity in the process development laboratory by:
Reduced experimental time: the time-scale for performing screening experiments can be reduced from weeks to hours.
Low sample consumption: new format significantly reduces sample consumption.
Increased process understanding: exploring an enlarged experimental space allows for a significant increase in process understanding.
