کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
6451962 | 1416984 | 2017 | 8 صفحه PDF | دانلود رایگان |
- Product quality is comparable between continuous and batch protein A chromatography.
- Use of continuous chromatography allows for 420% productivity increase.
- Buffer amounts can be reduced by 30-40% for continuous protein A chromatography.
- Continuous chromatography reduces cost of goods by 300% for the protein A step.
The protein A capture step is the main cost-driver in downstream processing, with high attrition costs especially when using protein A resin not until end of resin lifetime. Here we describe a feasibility study, transferring a batch downstream process to a hybrid process, aimed at replacing batch protein A capture chromatography with a continuous capture step, while leaving the polishing steps unchanged to minimize required process adaptations compared to a batch process. 35Â g of antibody were purified using the hybrid approach, resulting in comparable product quality and step yield compared to the batch process. Productivity for the protein A step could be increased up to 420%, reducing buffer amounts by 30-40% and showing robustness for at least 48Â h continuous run time. Additionally, to enable its potential application in a clinical trial manufacturing environment cost of goods were compared for the protein A step between hybrid process and batch process, showing a 300% cost reduction, depending on processed volumes and batch cycles.
Journal: Journal of Biotechnology - Volume 259, 10 October 2017, Pages 213-220