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Relative cost-effectiveness modeling to understand the value of preparative chiral separations in pharmaceutical R&D

JEFFREY P. KIPLINGER

Averica Discovery Services Inc.
260 Cedar Hill Street, Marlborough, MA 01752, USA

KEYWORDS: Supercritical fluid chromatography SFC, chiral drugs, preparative chromatography, batch chromatography.
ABSTRACT:
Strategy during early drug development requires attention to the profiling and de-risking of the drug candidate and to planning for supply as the preclinical and clinical programs progress.  Supplying chiral drug candidates as single stereoisomers adds a layer of complexity.  Chiral resolution by chromatography is considered an expensive alternative for large scale production, but in preclinical development it may not be cost effective to invest in a later stage production process.  In this article, we discuss ways to improve the cost equation in favor of chromatography – to ensure that near term program needs are met and to reduce the costs of large scale or commercial production.



Drug development is an increasingly long and expensive process.  While much of the cost comes from risk management, much comes from efforts to develop and use the best scientific knowledge when intending to give a new therapy to humans. ...
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