作者
Gioacchino Luca Losacco, Michael B Hicks, Jimmy O DaSilva, Heather Wang, Miraslava Potapenko, Fuh-Rong Tsay, Imad A Haidar Ahmad, Ian Mangion, Davy Guillarme, Erik L Regalado
发表日期
2022/5
期刊
Analytical and Bioanalytical Chemistry
卷号
414
期号
12
页码范围
3581-3591
出版商
Springer Berlin Heidelberg
简介
Bioprocess development of increasingly challenging therapeutics and vaccines requires a commensurate level of analytical innovation to deliver critical assays across functional areas. Chromatography hyphenated to numerous choices of detection has undeniably been the preferred analytical tool in the pharmaceutical industry for decades to analyze and isolate targets (e.g., APIs, intermediates, and byproducts) from multicomponent mixtures. Among many techniques, ion exchange chromatography (IEX) is widely used for the analysis and purification of biopharmaceuticals due to its unique selectivity that delivers distinctive chromatographic profiles compared to other separation modes (e.g., RPLC, HILIC, and SFC) without denaturing protein targets upon isolation process. However, IEX method development is still considered one of the most challenging and laborious approaches due to the many variables …
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