The use of SMB for the manufacture of enantiopure drug substances: From principles to cGMP compliance
by Novasep Inc.
In May 1992, the U.S. Food and Drug Administration issued a policy statement for the development of stereoisomeric drugs. The statement focused on the study and development of single enantiomers (enantiopure) and racemic drugs. This white paper by Novasep Inc. describes the use of simulated moving bed (SMB) technology in manufacturing enantiopure drug substances. It also explains basic principles, technical aspects and operating principles of SMB, and provides calculations relevant to SMB system operation under linear and nonlinear adsorption isotherm conditions.
| Published: | 2006 |
| Format: | |
| Length: | 34 pages |
| Type: | White paper |
| Language: | English |
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