GE offers new kit to streamline process development

By Pete Mansell

- Last updated on GMT

Related tags: Chromatography, Ge healthcare

Two products aimed at enhancing the efficiency of process
development in biopharmaceutical manufacturing are the latest
offerings from GE Healthcare, the UK-based medical technology and
services company.

The new launches are PreDictor 96-well filter plates and HiScreen columns prepacked with GE Healthcare's BioProcess chromatography media. The products can be used independently or as consecutive steps in a workflow to screen and optimise chromatographic conditions for bioseparations, the company noted. The PreDictor 96-well plates support high-throughput process development (HTPD) by allowing parallel screening of chromatographic conditions either manually or in an automated workflow. Prefilled with defined amounts of BioProcess chromatography media - Capto or MabSelect media, in the case of first-generation plates - they allow fast and efficient evaluation of up to 96 chromatography conditions for binding, washing or elution, as well as media benchmarking, with minimal buffer and sample and buffer consumption, GE Healthcare explained. Data generated using the PreDictor plates show good correlation with data obtained in chromatography columns, making the plates "an excellent tool for initial screening of process conditions​", it added. The net result of the PreDictor plates combined with the HTPD workflow is "more process information in less time and with less effort​", the company said. The filter plates measure 127.8 x 85.5 x 30.6 mm and are made of polypropylene and polyethylene. The well volume is 800 µl, with a working volume per well of 100-300 µl. PreDictor 96-well plates can be used with centrifugation or vacuum protocols, manually, or in automated robotic systems. The HiScreen columns are prepacked with a choice of 13 different BioProcess chromatography media, such as the various MabSelect and Capto media or five different hydrophobic interaction chromatography media based on Sepharise Fast Flow. The MabSelect range are protein A-derived media for capturing monoclonal antibodies, while Capto media are intended for general use in large-scale bioprocess operations. The hydrophobic interaction chromatography media (e.g., HiScreen Phenyl FF (high sub), HiScreen Butyl FF) are all based on the highly cross-linked beaded agarose matrix Sepharose Fast Flow, but with different immobilised hydrophobic ligands. They are for capture and intermediate purification, offering "excellen​t" flow properties and high physical and chemical stability, GE Healthcare noted. The BioProcess chromatography media have been specifically designed to meet the demands of industrial biotechnology, having passed "the rigorous selection requirements for the process scale downstream processing of biopharmaceuticals​", it pointed out. GE Healthcare says the HiScreen columns are ideal for method optimisation and parameter screening. The 10 cm bed height gives enough residence time to serve as a basis for linear process scale-up and, if needed, two columns can easily be connected in series to boost the bed height to 20cm. The small bed volume makes for fast results and minimal sample/buffer consumption, the company added. And the robustness of the incorporated media allows for repeated use with reproducible results, scaleable to BioProcess columns packed with the same media using the same linear fluid velocity.

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