Datasheet: PreDictor* 96-Well Filter Plates And Assist Software

PreDictor* 96-well filter plates are prefilled with Cytiva BioProcess chromatography media. PreDictor plates support high-throughput process development (HTPD) by allowing parallel screening of chromatographic conditions, either in a manual or in an automated workflow. Assist software supports the PreDictor workflow from set-up of experimental design to data evaluation. Data generated using PreDictor plates show good correlation with data from chromatography columns, making the plates an excellent tool for initial screening of process conditions.

Using PreDictor plates and Assist software shortens time-to-clinic and increases productivity in the process development lab 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

High-throughput process development for increased process understanding Development of robust purification processes requires significant time and resources. The Quality by Design initiative by the FDA may put additional demands on process development work because a higher degree of process understanding is needed. This understanding can be obtained if a larger experimental space is investigated and/or more detailed studies are performed. Employing high-throughput techniques for process development aids in addressing these challenges.

HTPD is a new way of working that shortens development time and increases the amount of information available during early process development, while keeping sample consumption low. Chromatographic conditions are evaluated in a parallel manner using 96-well filter plates. As a result, a large number of experimental conditions may be evaluated simultaneously. This allows screening of a large experimental space to identify the sub-space that is favorable with respect to one or several defined responses. Once this sub-space has been found, optimization and scale-up may be done on columns and ÄKTA design systems.