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Emerging Raman Applications and Techniques in Biomedical and Pharmaceutical Fields pp 241–262Cite as

Raman Spectroscopy: A Strategic Tool in the Process Analytical Technology Toolbox

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Part of the book series: Biological and Medical Physics, Biomedical Engineering ((BIOMEDICAL))

Abstract

An overview of the role and use of Raman spectroscopy for advanced process measurements is presented. Special emphasis is given to the potential of Raman spectroscopy as a tool for assessment, monitoring and advanced control of chemical content and crystallinity/polymorphism during pharmaceutical processing. As a Process Analytical Technology (PAT) tool, Raman spectroscopy can add value to both product/process development and to manufacturing processing. The wide range of PAT examples that are reviewed in this chapter emanates from emerging applications in primary and secondary manufacturing processing and in bioprocessing. In addition, strategies and the special requirements on Raman instrumentation for PAT are discussed.

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References

  1. Guidance for Industry, PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Re16 Johansson et al. search (CDER), Center for Veterinary, Medicine (CVM), Office of Regulatory Affairs (ORA), Pharmaceutical CGMPs, September 2004. URL: http://www.fda.gov/cder/guidance/6419fnl.htm. and U.S. Food and Drug Administration (FDA) PAT web site: http://www.fda.gov/cder/OPS/PAT.htm

  2. European Medicines Agency (EMEA) PAT web site: http://www.emea.eu.int/Inspections/PAThome.html

  3. ICH Q8A Pharmaceutical Development, ICH guidance for industry, May 2006, and ICH Q9A Quality Risk Management, ICH guidance for industry, June 2006, and, ICH Q10 Quality Systems, ICH draft guidance for industry, May 2007, and FDA Guidance for Industry, Process Validation: General Principles and Practices, Nov 2008. All are accessible at FDA web site: http://www.fda.gov/cder/guidance/

  4. C. Potter, S. Folestad, R. Beerbohm, G. Muirhead, S. Roenninger, A. Coupe, A. Swanson, F. Erni, G. Fischer, A guide to EFPIA’s mock P.2 document. Pharm. Technol. Int. 18(12), 39–44 (2006)

    Google Scholar 

  5. J.B. Callis, D.L. Illman, B.R. Kowalski, Process analytical chemistry. Anal. Chem. 59, 624A–637A (1987)

    Article  Google Scholar 

  6. J. Workman, M. Koch, D.J. Veltkamp, Anal. Chem. 75, 2859–2876 (2003)

    Article  Google Scholar 

  7. J. Workman, M. Koch, D.J. Veltkamp, Anal. Chem. 77, 3789–3806 (2005)

    Article  Google Scholar 

  8. J. Workman, M. Koch, D.J. Veltkamp, Anal. Chem. 79, 4345–4364 (2007)

    Article  Google Scholar 

  9. T.F. Cooney, H.T. Skinner, S.M. Angel, Appl. Spectrosc. 50, 836–848 (1996)

    Article  ADS  Google Scholar 

  10. T.F. Cooney, H.T. Skinner, S.M. Angel, Appl. Spectrosc. 50, 849–860 (1996)

    Article  ADS  Google Scholar 

  11. G.E. Walrafen, J. Stone, Appl. Spectrosc. 29, 337–344 (1975)

    Article  ADS  Google Scholar 

  12. M.L. Myrick, S.M. Angel, Appl. Spectrosc. 44, 565–570 (1990)

    Article  ADS  Google Scholar 

  13. V.S. Tumuluri, M.S. Kemper, I.R. Lewis, S. Prodduturi, S. Majumdar, B.A. Avery, M.A. Repka, Int. J. Pharm. 357, 77–84 (2008)

    Article  Google Scholar 

  14. S. Barnes, J. Gillian, D. Burton, D. Ertl, Am. Pharm. Rev. 11, 80–85 (2008)

    Google Scholar 

  15. T.R.M. De Beer, C. Bodson, B. Dejaegher, B. Walczak, P. Vercruysse, A. Burggraeve, A. Lemos, L. Delattre, Y.V. Heyden, J.P. Remon, C. Vervaet, W.R.G. Baeyens, J. Pharm. Biomed. Anal. 48, 772–779 (2008)

    Article  Google Scholar 

  16. G.M. Walker, S.E.J. Bell, K. Greene, D.S. Jones, G.P. Andrews, Chem. Eng. Sci. 64, 91–98 (2009)

    Article  Google Scholar 

  17. D.S. Hausman, R.T. Cambron, A. Sakr, Int. J. Pharm. 299, 19–33 (2005)

    Article  Google Scholar 

  18. T.R.M. De Beer, W.R.G. Baeyens, J. Ouyang, C. Vervaet, J.P. Remon, Analyst 131, 1137–1144 (2006)

    Article  ADS  Google Scholar 

  19. J. Johansson, S. Pettersson, S. Folestad, J. Pharm. Biomed. Anal. 39, 510–516 (2005)

    Article  Google Scholar 

  20. P. Matousek, A.W Parker, Appl. Spectrosc. 60, 1353–1357 (2006)

    Article  ADS  Google Scholar 

  21. P. Matousek, A.W Parker, J. Raman Spectrosc. 38, 563–567 (2007)

    Article  ADS  Google Scholar 

  22. J. Johansson, A. Sparén, O. Svensson, S. Folestad, M. Claybourn, Appl. Spectrosc. 61, 1211–1218 (2007)

    Article  ADS  Google Scholar 

  23. S. Folestad, J. Johansson, Eur. Pharm. Rev. 8, 36–42 (2003)

    Google Scholar 

  24. J. Rantanen, J. Pharm. Pharmacol. 59, 171–177 (2007)

    Article  Google Scholar 

  25. E.W. Ciurczak, Pharm. Manuf. July/August 18–26 (2008)

    Google Scholar 

  26. G. Fini, J. Raman Spectrosc. 35, 335–337 (2004)

    Article  ADS  Google Scholar 

  27. C.J. Strachan, T. Rades, K.C. Gordon, J. Rantanen, J. Pharm. Pharmacol. 59, 179–192 (2007)

    Article  Google Scholar 

  28. G. Fevotte, Chem. Eng. Res. Des. 85, 906–920 (2007)

    Article  Google Scholar 

  29. Z.Q. Yu, J.W. Chew, P.S. Chow, R.B. Tan, Eng. Res. Des. 85, 893–905 (2007)

    Article  Google Scholar 

  30. A.M. Schwartz, K.A. Berglund, J. Cryst. Growth 203, 599–603 (1999)

    Article  ADS  Google Scholar 

  31. A.M. Schwartz, K.A. Berglund, J. Cryst. Growth 210, 753–760 (2000)

    Article  ADS  Google Scholar 

  32. R.E. Tamagawa, E.A. Miranda, K.A. Berglund, Cryst. Growth Des. 2, 263–267 (2002)

    Article  Google Scholar 

  33. C. Starbuck, A. Spartalis, L. Wai, J. Wang, P. Fernandez, C.M. Lindeman, G.X. Zhou, Z. Ge, Cryst. Growth Des. 2, 515–522 (2002)

    Article  Google Scholar 

  34. P. Agrawal, K.A. Berglund, Cryst. Growth Des. 3, 941–946 (2003)

    Article  Google Scholar 

  35. T. Ono, J.H. ter Horst, P.J. Jansens, Cryst. Growth Des. 4, 465–469 (2004)

    Article  Google Scholar 

  36. J.A. Falcon, K.A. Berglund, Cryst. Growth Des. 4, 457–463 (2004)

    Article  Google Scholar 

  37. Y. Hu, J.K. Liang, A.S. Myerson, L.S. Taylor, Ind. Eng. Chem. Res. 44, 1233–1240 (2005)

    Article  Google Scholar 

  38. R. Kobayashi, Y. Fujimaki, T. Ukita, Y. Hiyama, Org. Process Res. Dev. 10, 1219–1226 (2006)

    Article  Google Scholar 

  39. H. Qu, M. Louhi-Kultanen, J. Rantanen, J. Kallas, Cryst. Growth Des. 6, 2053–2060 (2006)

    Article  Google Scholar 

  40. J. Schöll, D. Bonalumi, L. Vicum, M. Mazzotti, M. Müller, Cryst. Growth Des. 6, 881–891 (2006)

    Article  Google Scholar 

  41. A. Caillet, F. Puel, G. Fevotte, Int. J. Pharm. 307, 201–208 (2006)

    Article  Google Scholar 

  42. E.S. Ferrari, R.J. Davey, Cryst. Growth Des. 4, 1061–1068 (2004)

    Article  Google Scholar 

  43. B. O’Sullivan, P. Barret, G. Hsiao, A. Carr, B. Glennon, Org. Process Res. Dev. 7, 977–982 (2003)

    Article  Google Scholar 

  44. M. Savolainen, K. Jouppila, O. Pajamo, L. Christiansen, C. Strachan, M. Karjalainen, J. Rantanen, J. Pharm. Pharmacol. 59, 161–170 (2007)

    Article  Google Scholar 

  45. J. Rantanen, H. Wikström, F.E. Rhea, L.S. Taylor, Appl. Spectrosc. 59, 942–951 (2005)

    Article  ADS  Google Scholar 

  46. S. Santesson, J. Johansson, L.S. Taylor, I. Levander, S. Fox, M. Sepaniak, S. Nilsson, Anal. Chem. 75, 2177–2180 (2003)

    Article  Google Scholar 

  47. O. Svensson, M. Josefson, F.W. Langkilde, Chemometr. Intell. Lab. Syst. 49, 49–66 (1999)

    Article  Google Scholar 

  48. C.A. McGill, A. Nordon, D. Littlejohn, Analyst 127, 287–292 (2002)

    Article  ADS  Google Scholar 

  49. M. Ehly, P.J. Gemperline, A. Nordon, D. Littlejohn, J.K. Basford, M. DeCecco, Anal. Chim. Acta 595, 80–88 (2007)

    Article  Google Scholar 

  50. M.M. Reis, P.H.H. Araújo, C. Sayer, R. Giudici, Anal. Chim. Acta 595, 257–265 (2007)

    Article  Google Scholar 

  51. D. Jayawickrama, A. El Hagrasy, S.-Y. Chang, Am. Pharm. Rev. 9, 10–17 (2006)

    Google Scholar 

  52. H. Wikström, P.J. Marsac, L.S. Taylor, J. Pharm. Sci. 94, 209–219 (2005)

    Article  Google Scholar 

  53. H. Wikström, I.R. Lewis, L.S. Taylor, Appl. Spectrosc. 59, 934–941 (2005)

    Article  ADS  Google Scholar 

  54. G. Walker, S.E.J. Bell, M. Vann, D.S. Jones, G. Andrews, Chem. Eng. Sci. 62, 3832–3838 (2007)

    Article  Google Scholar 

  55. T.R.M. De Beer, M. Allesø, F. Goethals, A. Coppens, Y. Vander Heyden, H. Lopez De Diego, J. Rantanen, F. Verport, C. Vervaet, J.P. Remon, W.R.G. Baeyens, Anal. Chem. 79, 7992–8003 (2007)

    Article  Google Scholar 

  56. S. Romero-Torres, H. Wikström, E.R. Grant, L.S. Taylor, J. Pharm. Sci. Technol. 61, 131–145 (2007)

    Google Scholar 

  57. H. Wikström, S. Romero-Torres, S. Wongweragiat, J.A. SuartWilliams, E.R. Grant, L.S. Taylor, Appl. Spectrosc. 60, 672–681 (2006)

    Article  ADS  Google Scholar 

  58. A.C. Williams, V.B. Cooper, L. Thomas, L.J. Griffith, C.R. Petts, S.W. Booth, Int. J. Pharm. 275, 29–39 (2004)

    Article  Google Scholar 

  59. S. Romero-Torres, J.D. Pérez-Ramos, K.R. Morris, E.R. Grant, J. Pharm. Biomed. Anal. 38, 270–274 (2005)

    Article  Google Scholar 

  60. J.F. Kauffman, M.D. Dellibovi, C.R. Cunningham, J. Pharm. Biomed. Anal. 43, 39–48 (2007)

    Article  Google Scholar 

  61. I. Jedvert, M. Josefson, F. Langkilde, J. Near Infrared Spectrosc. 6, 279–289 (1998)

    Article  ADS  Google Scholar 

  62. M. Kim, H. Chung, Y. Woo, M. Kemper, Anal. Chim. Acta 579, 209–216 (2006)

    Article  Google Scholar 

  63. J. Kim, J. Noh, H. Chung, Y.A. Woo, M. Kemper, Y. Lee, Anal. Chim. Acta 598, 280–285 (2007)

    Article  Google Scholar 

  64. M. Kim, H. Chung, Y. Woo, M.S. Kemper, Anal. Chim. Acta 587, 200–207 (2007)

    Article  Google Scholar 

  65. A.A. Gowen, C.P. O’Donnell, P.J. Cullen, S.E.J. Bell, Eur. J. Pharm. Biopharm. 69, 10–22 (2008)

    Article  Google Scholar 

  66. U. von Stockar, S. Valentinotti, I. Marison, C. Cannizzaro, C. Herwig, Biotechnol. Adv. 21, 417–430 (2003)

    Article  Google Scholar 

  67. T. Becker, B. Hitzmann, K. Muffler, R. Pörtner, K.F. Reardon, F. Stahl, R. Ulber, Adv. Biochem. Eng. Biotechnol. 105, 249–293 (2007)

    Google Scholar 

  68. R. Ulber, J.-G. Frerichs, S. Beutel, Anal. Bioanal. Chem. 376, 342–348 (2003)

    Google Scholar 

  69. M.-N. Pons, S. Le Bonté, O. Potier, J. Biotechnol. 113, 211–230 (2004)

    Article  Google Scholar 

  70. A.C. McGovern, D. Broadhurst, J. Taylor, N. Kaderbhai, M.K. Winson, D.A. Small, J.J. Rowland, D.B. Kell, R. Goodacre, Biotechnol. Bioeng. 78, 527–538 (2002)

    Article  Google Scholar 

  71. H.L.T. Lee, P. Boccazzi, N. Gorret, R.J. Ram, A.J. Sinskey, Vib. Spectrosc. 35, 131–137 (2004)

    Article  ADS  Google Scholar 

  72. S.J. Clarke, R.E. Littleford, W.E. Smith, R. Goodacre, Analyst 130, 1019–1026 (2005)

    Article  ADS  Google Scholar 

  73. T.R.M. De Beer, W.R.G. Baeyens, Y. Vander Heyden, J.P. Remon, C. Vervaet, F. Verport, Eur. J. Pharm. Sci. 30, 229–235 (2007)

    Article  Google Scholar 

  74. C. Abrahamsson, A. Löwgren, B. Strömdahl, T. Svensson, S. Andersson-Engels, J. Johansson, S. Folestad, Suppl. Spectr. 59, 1381–1387 (2005)

    Article  ADS  Google Scholar 

  75. O. Berntsson, L.-G. Danielsson, S. Folestad, Anal. Chim. Acta 431, 125–131 (2001) and 91–98 (2009)

    Google Scholar 

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Author information

Authors and Affiliations

  1. Pharmaceutical & Analytical Development, AstraZeneca R&D, Mölndal, Sweden

    Jonas Johansson & Staffan Folestad

  2. Pharmaceutical & Analytical Development, AstraZeneca R&D, Macclesfield, UK

    Mike Claybourn

Authors
  1. Jonas Johansson
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  2. Mike Claybourn
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  3. Staffan Folestad
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Correspondence to Jonas Johansson .

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Editors and Affiliations

  1. Science & Technology Facilities Council, Central Laser Facility, Didcot, Oxon., OX11 0QX, United Kingdom

    Pavel Matousek

  2. Dept. Chemistry, University of Michigan, Ann Arbor, 48109-1055, U.S.A.

    Michael D. Morris

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Johansson, J., Claybourn, M., Folestad, S. (2010). Raman Spectroscopy: A Strategic Tool in the Process Analytical Technology Toolbox. In: Matousek, P., Morris, M. (eds) Emerging Raman Applications and Techniques in Biomedical and Pharmaceutical Fields. Biological and Medical Physics, Biomedical Engineering. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-02649-2_10

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  • DOI: https://doi.org/10.1007/978-3-642-02649-2_10

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