Method optimization and parameter screening

When developing a new process, parameters such as selectivity, capacity, and binding and elution conditions must be screened at smaller scale to save time and money. We suggest starting with high‑throughput parallel screening of process conditions which is easily performed using 96‑well PreDictor™ plates prefilled with BioProcess™ resin. During the process development, HiScreen™ prepacked column format is available for further method optimization, or for the fine-tuning and verification of parameters.

Scale-up

Scale‑up of a chromatography step can be as straightforward as increasing column diameter to accommodate a larger feed volume while keeping the bed height and the linear flow velocity constant. The 10 cm bed height of HiScreen™ columns gives sufficient residence time to serve as the basis for linear process scale‑up. However, when needed, two columns can easily be connected in series to increase the bed height.

Capto™ Octyl – a high-flow and high-capacity HIC resin

Capto™ Octyl hydrophobic interaction chromatography resin has an octyl ligand for the capture and intermediate purification of monoclonal antibodies (mAbs), mAb variants, and other biomolecules. It combines high capacity, narrow specification range, high flow rate, and low backpressure to meet the demands of large-scale biopharmaceutical manufacturing.

Not sure which HIC resin you should use? We recommend starting with one of the kits below:

• PreDictor™ Capto™ HIC screening kit, a set of 96-well plates prefilled with six Capto™ HIC resins for use in high-throughput process development (HTPD)
• HiTrap™ Capto™ HIC selection kit, a set of five Capto™ HIC resins in HiTrap™ columns for resin selection and condition screening

Capto™ Octyl is available in other formats (Figure 1):

These formats support various scales of work from process development screening to GMP manufacturing.

• Bulk resin bottles and containers of Capto™ Octyl resin for column packing
• PreDictor™ Capto™ Octyl RoboColumn™ units, miniaturized columns for HTPD
• PreDictor™ Capto™ Octyl multiwell plates, 96-well plates for high-throughput screening or process development
• HiTrap™ Capto™ Octyl 1 mL and 5 mL columns for easy use with a syringe, peristaltic pump, or chromatography system
• ReadyToProcess™ Capto™ Octyl columns, in various sizes for scale-up and GMP manufacturing

Fig 1. Prepacked chromatography formats available from Cytiva to support various scales, from screening to GMP manufacturing.