Contichrom as Enabling Purification Solution

The ContiChrom platform has enabling features helping to discover and isolate novel leads as well as develop 2nd generation products due to some unique features:

• The use of small-particle size, high resolution analytical columns for semi-preparative isolation of leads
• The continuous chromatography principle in countercurrent mode allowing to define high purity and yield as fixed parameters
• The automated operations mode allowing continuous collection of target lead

After discovery of a new lead by analytical chromatography, there is a major problem to purify a chosen lead, so that this specific lead can be studied in the absence of other interfering substances. With classical HPLC systems, several hundred runs may be needed to isolate sufficient target lead from a complex mixture (see calculation example in the download section). In contrast, using the ContiChrom platform allows to isolate the target lead continuously.

The ability of the ContiChrom platform technology to isolate components from complex mixtures with high selectivity and yield creates the possibility to develop new medicines that could not have been isolated economically before. Typical examples are shown in the "Industries and Products" subsection on the left. This provides a best in class enabling tool that no other technology can offer with the same performance, scalability and precision.

Besides the development of novel biopharmaceutical drugs, the technology is useful for the development and production of 2nd -generation products ("biobetters") that have superior therapeutic potential and/or better safety profiles compared to the original drug.

Besides its enabling features, the ContiChrom pilot equipment also allows to rapidly develop economic processes and to fix defined product specifications allowing executing the clinical programs while retaining the fixed product profile after scale up to production scale.

Finally, new products can be developed from existing drugs by refining product specifications thereby generating 2 nd generation products, completing the lifecycle of the drug.

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Such examples include:

• Discovery: the mining for new molecules relying on the high resolution of ContiChrom together with small particle resins

• Discovery: the purification of leads in significant amounts for further characterization

• The automated process development obtaining high yield and purity with defined product specifications that can be retained during development and scale-up

• The production to high purity of large volume products as for example fatty acids, plasma proteins where low CAPEX and COG are critical business parameters

• The economic production of 2nd generation biologics, e.g. PEGylated glycoproteins, monoclonal antibody variants and bi-specific antibodies

• To obtain a scalable target product specifications, e.g. for low molecular weight heparins

Please refer to the case studies in the download section for more information.