olivier_ludemann_hombourger - 1 Novasep 2 Novasep...

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Unformatted text preview: 1 Novasep 2 Novasep Preparative Preparative chromatography chromatography an an appropriate and appropriate and versatile solution for versatile solution for the the purification of APIs purification of APIs from early from early stage to stage to commercial commercial scale scale Olivier Ludemann-Hombourger , R&D Director, NOVASEP Process 3 Novasep Introduction Introduction Chromatography is known as an efficient purification process Widely used in development labs. Industrial multi-column processes has been developed by NOVASEP for the purification of APIs. quite a big gap ??? 4 Novasep Content Content The purification needs from discovery to commercial stage Modern batch chromatography New preparative processes : CYCLOJET VARICOL Comparison of BATCH, CYCLOJET and VARICOL Supercritical Fluid Chromatography 5 Novasep Different Needs at Different Stages of Development of a Pharmaceutical Drug Several steps in the development of an Active Pharmaceutical Ingredient. Screening of large libraries in discovery to the production of the hit molecule Specific constraints in the different stages Production Full Development Early Development Discovery 6 Novasep Different Needs at Different Stages of Development of a Pharmaceutical Drug Discovery : prep. Batch Chromatography is always used Early development : Chromatography is often used WHY ?- very fast development time- Quick way to isolate mgs to kgs quantities. Production Full Development Early Development Discovery 7 Novasep Different Needs at Different Stages of Development of a Pharmaceutical Drug Latest development stage : Larger quantities required Selection of the production process, final optimization Process validation REQUISITE :- Cost is an issue at these stages- Mastering the process scale-up is a MUST Production Full Development Early Development Discovery 8 Novasep Selection Selection of of the the right right chromatography chromatography process process Batch chromatography is simple, easy, but is not the most efficient solution Several chromatography processes has been developed to improve the process performances Time to Market Purification cost Adapt the process to the purification problem : development stage/commercial 9 Novasep Analytical Preparative Small injections High efficiency High pressure Large injections Optimised efficiency Moderate pressure Minimised costs Batch Chromatography Batch Chromatography 10 Novasep Batch chromatography Batch chromatography 11 Novasep Batch chromatography : (R)evolution of the Batch chromatography : (R)evolution of the process over the last 20 years process over the last 20 years Limited number of fractions, automatic adjustment Large number of collected fractions, pooling, reprocessing Isocratic, solvent recycling Gradient mode often used Short retention time (minutes) Long retention time (hours, days) Small injected amount Large injected amount...
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This note was uploaded on 02/16/2010 for the course CHEM 589 taught by Professor -1 during the Fall '02 term at Pennsylvania State University, University Park.

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olivier_ludemann_hombourger - 1 Novasep 2 Novasep...

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