The cost pressure on biopharmaceuticals drives the industry towards exploring process intensification options, while maintaining or improving quality, stability, and manufacturability of the product. Traditionally, biomanufacturing is dominated by batch operations. Lately, however, continuous or connected biomanufacturing is being evaluated. While perfusion bioreactors are approved for use in several upstream processes, downstream processing has remained as a series of separate batch operations with hold-up tanks in between.<br/><br/>Continuous chromatography is applicable in different phases from drug discovery to production of biopharmaceuticals, for example, process development, including screening of suitable resins, and automated production of drug candidates in late research. In this talk, we present results from a case study on a scale-up of a periodic counter-current chromatography (PCC) mAb capture step using one and the same chromatography system, and what this means in terms of required productivity and efficiency. We also present data from a resin lifetime study using PCC. In addition to MabSelect SuRe™ resins, a new protein A resin with improved capacity and alkaline stability compared with its predecessors, was included in the study. Experimental data shows that the new Protein A resin retains a significantly higher relative dynamic binding capacity (DBC) after 50 cleaning-in-place (CIP) cycles with high concentration of NaOH compared with the other tested resins. PCC technology, together with high-capacity and alkaline-stable resins, has the potential to increase productivity, while reducing the size of the equipment needed for clinical and commercial productions.

Use of a continuous chromatography system for both resin screening and scale-up studies

255th National Meeting (2018)

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