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Can Analytical Methods using Monolithic Supports Be Validated?

Convective Interaction Media CIM® are polymer-based monolithic supports which were introduced for chromatographic analyses, in-process control, solid phase extraction and purification of target biomolecules, both on an analytical and on a preparative scale1, 2. CIM supports allow high-resolution separations which can be carried out within seconds in the case of analytical units. This is due to predominantly convective mass transport of biomolecules between the mobile and stationary phases and very low dead volume of the separation unit.

One of the main concerns arising in the last few years was the batch-to-batch reproducibility in the manufacturing of the monoliths and possibility to use the monolithic supports for validated analytical methods. The batch-to-batch reproducibility of product preparation as well as its stability during the analytical work should be good enough to fulfill all the requests needed for a validated analytical method. To demonstrate that this is possible we have selected one complex example – the determination of impurities in immunoglobulins (IgGs) where a multidimensional, so called CLC (Conjoint Liquid Chromatography), approach combining the ion exchange and affinity chromatography was needed to properly analyze the sample.

Therefore, two CIM Protein G disks and one CIM QA disk were placed in series in one housing. Binding conditions were optimized in a way that IgGs bound on CIM Protein G disks while Transferrin and Albumin were separated on a CIM QA disk. A complete separation of all three proteins was achieved in five minutes.


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