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High-Throughput Process Development

Source: GE Healthcare Life Sciences

High-Throughput Process Development

Time-to-clinic and time-to-market are two key factors in successful biopharmaceutical development.

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Datasheet: PreDictor™ RoboColumn™

Time-to-clinic and time-to-market are two key factors in successful biopharmaceutical development. High-throughput process development (HTPD) shortens development time, while increasing the amount of information available for quality by design (QbD) approaches. Evaluation of chromatographic conditions can be performed in a high-throughput manner using PreDictor™ 96-well plates or PreDictor RoboColumn™ units with Assist software. A wide range of experimental conditions can be evaluated simultaneously, allowing characterization of the design space and helping to define the process parameters that need to be monitored and controlled. Smooth transfer to HiScreen™ and HiScale™ columns on the ÄKTA platform enables optimization, further characterization and scale-up.

PreDictor™ 96-well filter plates are prefilled with BioProcess™ chromatography media for ion exchange and antibody affinity chromatography.

PreDictor plates support high-throughput process development (HTPD) by allowing parallel screening of chromatography conditions for binding, wash, and elution.They can also be used for determination of adsorption isotherms.PreDictor plates can be operated in either a manual or 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.PreDictor plates and Assist software shorten time-to-clinic and improve productivity by:

  • Decreasing experimental time from weeks to hours
  • Reducing sample consumption
  • Increasing process understanding through exploring an enlarged experimental space.

 

PreDictor RoboColumn units are miniaturized chromatographic columns prepacked with BioProcess™ chromatography media (resin) from GE Healthcare. The columns are available for several chromatographic techniques such as ion exchange chromatography (IEX), affinity chromatography (AC), multimodal chromatography (MM), and hydrophobic interaction chromatography (HIC).

These miniaturized columns support HTPD using a robotic liquid handling workstation, such as Freedom EVO® from Tecan, for fully automated and parallel chromatographic separations. Perform HTPD work using PreDictor RoboColumn units, alone or as a complement to PreDictor plates.

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Datasheet: PreDictor™ RoboColumn™

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