Advances in de-Bottlenecking downstream processes. Reduce Process time, Processing Costs ( PrA) Facility Cost and Plant Footprint.

As titers have gone up in cell culture, more downstream bottlenecks have emerged. Columns have become larger, buffer volumes have gone up and expenses related to Protein A columns with antibody production have sky-rocketed. Facility size and footprint have become moving targets.

Sepragen has several advanced tools that help to these bottlenecks:

•       Radial flow Chromatography columns which are employed in the manufacture of 24 FDA approved drugs can enable 4X the flow rate of conventional columns reducing cycle times and enabling the use of smaller columns with less usage of expensive resins. They can be easily adapted for use with any resin. Also smaller footprint and costs are much lower.

•      Sepragen’s chromatography skids with 100:1 turn-down ratios can be employed across a wide range of columns enabling greater flexibility as columns sizes change. The chrom skids can also be used for uf/df and concentration providing greater flexibility in hardware usage. Sepragen’s Single-Use Chromatography Systems enable a customer to change out the flow-path in 20 minutes obviating the need for cleaning validation and ensuring flexible use in multiproduct facilities.

•      Buffer management is facilitated by Sepragen’s In Line buffer dilution systems. Pre-made buffer concentrates in totes can be used and these concentrated buffers diluted to the desired concentration at point-of-use enabling the move to smaller single use facilities with reduced tankage and cleaning needs.

Finally, Sepragen's latest break-through initiative in Process Integration and Continuous processing is ushering in a dramatic new round of cost and foot-print reduction for biosimilars and follow-on biologics not found elsewhere.

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