Product Development, GlaxoSmithKline, Platform Technology and Science, King of Prussia, Pennsylvania 19406, USA.
Chirality. 2011 Apr;23(4):361-6. doi: 10.1002/chir.20931. Epub 2011 Jan 6.
There are several approaches to produce enantiomerically pure drug substances, such as recrystallization, catalytic process (ligand and enzyme), indirect chromatographic resolution, and direct chromatographic resolution. However, the use of preparative chromatography with chiral stationary phases seems to be most effective for early phase projects, where the time and resources on the developments need to be minimized to get the drug candidates into the clinical studies. We showed that by following a well-defined process, chiral chromatography can be easily scaled up from an analytical system to a pilot plant system. We also used the results from a multicolumn continuous chromatography (MCC) study to conclude that MCC can be a cost-effective production method for chiral manufacturing.
有几种方法可以生产手性纯的药物物质，例如重结晶、催化过程（配体和酶）、间接色谱拆分和直接色谱拆分。然而，使用手性固定相进行制备色谱似乎对于早期阶段的项目最为有效，在这些项目中，需要将开发时间和资源最小化，以使候选药物进入临床研究。我们表明，通过遵循明确定义的过程，手性色谱可以很容易地从分析系统扩展到中试系统。我们还利用多柱连续色谱（MCC）研究的结果得出结论，MCC 可以成为手性制造的一种具有成本效益的生产方法。
