ケイデンス™ BioSMB Process System

Continuous Single-Use,
Multi-Column Chromatography
ケイデンスBioSMBプラットフォームは、ディスポーザブルに対応した高流速の流路を有する連続式マルチカラムクロマトグラフィーにより、実験室でのプロセス開発(PD)からGMPに準拠した製造まで、完全なスケールアップの解決策を提供します。The ケイデンス BioSMB Process system is specifically designed to allow users to convert an existing PD scale continuous purification into a process scale continuous purification based on feedstreams derived from fed batch bioreactors of up to 2000 L. The chromatographic process developed using the ケイデンス BioSMB PD system can be readily scaled to the ケイデンス BioSMB Process system without changing the sorbent, buffer system or product quality assays.BioSMB technology provides process consistency across all scales of operation while making it practical to implement in flexible, multi-product facilities.

  • Inherent unit operation efficiency of the BioSMB technology reduces the cost of chromatographic media by up to 80% without changing either the sorbent or buffer used in the chromatographic process.
  • Entire chromatographic process can be conducted in a smaller system using smaller column volumes with associated reductions in buffer that would be required in a standard batch process to produce the same amount of material.
  • The entire single-use flow path of the ケイデンス BioSMB Process system can be replaced within 30 minutes.
  • The valve system in the ケイデンス BioSMB Process system does not require cleaning or cleaning validation.
  • Ability to use up to 8 columns increases specific productivity and application flexibility.

利点

Batch chromatographic processing typically utilizes only 50% to 70% of the chromatographic column’s total binding capacity.The ケイデンス BioSMB Process system, on the other hand, uses a series of interconnected and substantially smaller columns.供給領域の第一カラムがブレークスルーに達すると、製品化合物は第二カラムで吸着されます。従って、バッチ式システムで利用できる動的結合容量を超えて、第一カラムを十分に活用することができます。多くの場合、平衡状態または静的結合容量に近い性能での作業が可能となり、クロマトグラフィーメディアの使用量を大幅に削減することにつながります。

The ケイデンス BioSMB Process system uses continuous countercurrent loading.This requires that the load zone must only accommodate the mass transfer zone, which generally represents a small percentage of a batch column.このため、非常に小型のシステムでプロセス全体を実施することが可能となり、クロマトグラフィーメディアは標準的なバッチ式プロセスより少ない量で済みます。By using up to 8 smaller prepacked columns on the ケイデンス BioSMB Process system, the need for packing skids, large stainless steel columns, and other support infrastructure is eliminated.

While competitive systems use a complex set of valves, the Pall BioSMB technology uses an integrated valve cassette specially designed and patented as a single-use component.この新しいバルブシステムでは、複雑な洗浄バリデーションプロセスを省略することができます。

The ability to use up to 8 columns with the ケイデンス BioSMB Process system enables a comprehensive range of capture and polishing steps such as in affinity, ion-exchange, mixed mode, hydrophobic interaction and size exclusion chromatography to be scaled up.The availability of up to 8 of columns provides a particular benefit to applications with feeds that have been concentrated and those with production titers greater than 5 g/L.

The ケイデンス BioSMB Process system is designed to be much more adept compared with following a simple chromatographic media optimization approach.As an example, the position of the buffer selection valves in the ケイデンス BioSMB Process system has been designed to contribute directly to process optimization in multiple ways.Since each column used with the ケイデンス BioSMB Process system is assigned a series of valves arranged in a single-use array, the result is that each pump is delivering a single fluid throughout the entire process and will never undergo composition gradients and/or wash steps.In addition, the system volume that actually is subject to composition changes in the ケイデンス BioSMB Process system is minimized and this eliminates many of the uncertainties associated with scale-up/scale-down, validation and process control.