Chapter 10. The Use of SMB for the Manufacture of Enantiopure Drug Substances: From Principle to cGMP Compliance

  1. Dr. Ganapathy Subramanian
  1. S.R. Perrin1 and
  2. R.M. Nicoud2

Published Online: 18 OCT 2001

DOI: 10.1002/3527600361.ch10

Chiral Separation Techniques: A Practical Approach, Second Edition

Chiral Separation Techniques: A Practical Approach, Second Edition

How to Cite

Perrin, S.R. and Nicoud, R.M. (2000) The Use of SMB for the Manufacture of Enantiopure Drug Substances: From Principle to cGMP Compliance, in Chiral Separation Techniques: A Practical Approach, Second Edition (ed G. Subramanian), Wiley-VCH Verlag GmbH, Weinheim, FRG. doi: 10.1002/3527600361.ch10

Editor Information

  1. 60B Jubilee Road, Littlebourne, Canterbury, Kent CT3 1TP, UK

Author Information

  1. 1

    Novasep Inc., 480 S. Democrat Road, Gibbstown, NJ 08027-1297, USA

  2. 2

    Novasep SAS, 15, Rue du Bois de la Champelle, Parc Technologique de Brabois, B. P. 50, 54502 Vandoeuvre-lès-Nancy Cedex, France

Publication History

  1. Published Online: 18 OCT 2001
  2. Published Print: 29 NOV 2000

ISBN Information

Print ISBN: 9783527298754

Online ISBN: 9783527600366

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Keywords:

  • manufacture of enantiopure drug substances;
  • market;
  • processes;
  • development;
  • conditions;
  • process design;
  • production;
  • manufacturing

Summary

  • Introduction

    • FDA as the driving force: (enantiopure drugs and compliance)

      • Market exclusivity: newly approved drug substances

      • Fixed-combination dosage: enantiopure drug substances

      • Pharmaceutical industry: mergers

  • Chromatographic processes

    • SMB: comparisons to batch chromatography

    • Illustrations of SMB processes

  • SMB as a development tool

    • Basic principles and technical aspects

    • Operating conditions

      • Step A: aquisition of relevant physico-chemical parameters

      • Step B: calculation of TMB

      • Step C: calculation of SMB

  • Example of process design

    • Manufacture of enatiopure drug substances

      • Gathering physico-chemical parameters

      • SMB: linear conditions

      • SMB: nonlinear conditions

  • SMB as a production tool

    • cGMP compliance

      • Manufacturing and process controls

      • Solvent recovery

      • In-process testing

      • Calculation of yields and definition of batch

    • Process validation

  • SMB accepted for manufacturing

    • Practical implications for manufacturing

  • Conclusions