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首页> 外文会议>Integrated continuous biomanufacturing II >GlycoExpress: A Toolbox For The High Yield Production Of Glycooptimized Fully Human Biopharmaceuticals In Perfusion Bioreactors At Different Scales
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GlycoExpress: A Toolbox For The High Yield Production Of Glycooptimized Fully Human Biopharmaceuticals In Perfusion Bioreactors At Different Scales

机译：GlycoExpress：在不同规模的灌注生物反应器中高产量生产糖基优化的完全人类生物制药的工具箱

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Background and Novelty: Glycosylation is one of the ma□or post-translational modifications of biotherapeutics important for bioactivity, bioavailability, immunogenicity and patient coverage. By establishment of the GlycoExpress™ toolbox (GEX™) we have generated a set of glycoengineered human cell lines for the high yield production of fully human glycoproteins to optimize the glycosylation of antibodies and non-antibody biotherapeutics for improvement of the clinical efficacy and side effects. The system is biotechnologically superior in □uality, reproducibility and yield compared to other including conventional production systems. All four clinical products derived from GlycoExpress cells are produced using a perfusion bioreactor system in order to assure highest possible product Duality and reproducibility combined with high yield production. □ethods: GlycoExpress cells producing mAb are cultivated with perfusion bioreactor systems applying different cell retention mechanisms such as centrifugation (centritech) or alternating tangential flow (ATF) filtration at different scales. A 10 mL based down-scale perfusion system with good comparability to larger scale cultivations was also established. Growth, product yield and product □uality, especially glycosylation, are evaluated during the cultivation. Conclusion: Perfusion culture helps to keep cells in the optimal growing and production phase over the production process which leads to highly stable product □uality allowing a flexible duration of the run in one batch size in combination with stable high productivity of the cells over time. Furthermore the product □ualities produced in different scales ranging from 10 mL to 1000 L cultivation vessels are highly comparable.
机译：背景和新颖性：糖基化是生物治疗药物的翻译后修饰之一，对生物活性，生物利用度，免疫原性和患者覆盖率具有重要意义。通过建立GlycoExpress™工具箱（GEX™），我们已经产生了一组糖工程化的人细胞系，可高产量生产完全的人糖蛋白，从而优化抗体和非抗体生物治疗剂的糖基化，从而改善临床疗效和副作用。与其他包括常规生产系统的系统相比，该系统在生物技术，质量，可重复性和产量方面都更加出色。使用灌注生物反应器系统生产源自GlycoExpress细胞的所有四种临床产品，以确保尽可能高的产品对偶性和可重复性以及高产量。 □方法：用灌注生物反应器系统培养产生mAb的GlycoExpress细胞，该系统采用不同的细胞保留机制，例如不同规模的离心（centritech）或交替切向流（ATF）过滤。还建立了一个与大型培养物具有良好可比性的基于10 mL的小型灌流系统。在培养过程中评估生长，产品产量和产品质量，尤其是糖基化。结论：灌注培养有助于在整个生产过程中将细胞保持在最佳的生长和生产阶段，从而实现高度稳定的产品质量，允许灵活的批量生产时间，并随着时间的推移保持稳定的高生产率。此外，从10毫升到1000升的培养皿，以不同规模生产的产品质量具有高度可比性。

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