Traditional packed bed chromatography has been a workhorse for the biomanufacturing industry for the past five decades, deployed in the production of everything from plasma proteins, through monoclonal antibodies to modern applications such as the manufacture of cell based vaccines. A limitation of this technology has been the inherent mass transfer constraints, inversely linking how quickly processes can be operated, and the mass throughput of the operation. As a result, it has been the long held wisdom that packed bed chromatography is a capacity and productivity bottleneck for most modern biomanufacturing facilities.<br/>Nano-fibre based chromatographic media developed by Puridify, subsequently acquired by GE Healthcare, decouples mobile phase flowrate and protein mass transfer, enabling chromatography cycles to be completed in single digit minutes, rather than hours. The work presented will highlight how this shift in processing paradigm has been utilised at GSK. Case studies will illustrate the process development work that has been performed using the PrismA Fibro for antibody capture, and to evaluate its performance, particularly at pilot scale. The data gained from these studies has been used to map out potential implementation strategies, providing either an increase in facility flexibility and therefore utilisation and/or reducing the CoGs, particularly in the context of clinical manufacturing.<br/>Furthermore, whilst the operational and financial benefits of adopting Fibro technology can be easily conceptualised, perhaps less well documented is the potential for using this technology to facilitate more rapid process development. The work presented will show how PrismA Fibro has been implemented at GSK, outside of the DSP space to which its application is most immediately apparent, in order to facilitate more rapid cell line screening and selection.

Next generation protein a capture: Harnessing the power of nanofiber technology to intensify biomanufacturing and facilitate rapid process development

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.