410
B. Igne and E. W. Ciurczak
15. European Medicine Agency, Guideline on the Use of Near Infrared Spectroscopy by the
Pharmaceutical Industry and the Data Requirements for New Submissions and Variations.
2014
16. United States Food and Drug Administration, Draft Guidance—Development and Submission
of Near Infrared Analytical Procedures Guidance for Industry. 2015
17. T. Miyano, H. Nakagawa, T. Watanabe, H. Minami, H. Sugiyama, Operationalizing maintenance of calibration models based on near-infrared spectroscopy by knowledge integration. J.
Pharm. Innov. 10(4), 287–301 (2015)
18. M. Hoehse, J. Alves-Rausch, A. Prediger, P. Roch, C. Grimm, Near-infrared spectroscopy in
upstream bioprocesses. Pharm. Bioprocess 3, 153–172 (2015)
19. R.W. Silman, L.T. Black, K. Norris, Assay of solid–substrate fermentation by means of
reflectance infrared analysis. Biotechnol. Bioeng. 25(2), 603–607 (1983)
20. J. Crowley, S.A. Arnold, N. Wood, L.M. Harvey, B. McNeil, Monitoring a high cell density
recombinant Pichia pastoris fed-batch bioprocess using transmission and reflectance near
infrared spectroscopy. Enzyme Microb. Technol. 36(5), 621–628 (2005)
21. M. Goldfeld, J. Christensen, D. Pollard, E.R. Gibson, J.T. Olesberg, E.J. Koerperick, K. Lanz,
G.W. Small, M.A. Arnold, C.E. Evans, Advanced near-infrared monitor for stable real-time
measurement and control of Pichia pastoris bioprocesses. Biotechnol. Prog. 30(3), 749–759
(2014)
22. N. Petersen, P. Odman, A.E. Padrell, S. Stocks, A.E. Lantz, K.V. Gernaey, In situ near infrared
spectroscopy for analyte-specific monitoring of glucose and ammonium in streptomyces
coelicolor fermentations. Biotechnol. Prog. 26(1), 263–271 (2010)
23. L.O. Rodrigues, L. Vieira, J.P. Cardoso, J.C. Menezes, The use of NIR as a multi-parametric
in situ monitoring technique in filamentous fermentation systems. Talanta 75(5), 1356–1361
(2008)
24. M.J. McShane, G.L. Coté, Near-infrared spectroscopy for determination of glucose, lactate,
and ammonia in cell culture media. Appl. Spectrosc. 52(8), 1073–1078 (1998)
25. C.B. Lewis, R.J. McNichols, A. Gowda, G.L. Coté, Investigation of near-infrared spectroscopy
for periodic determination of glucose in cell culture media in situ. Appl. Spectrosc. 54(10),
1453–1457 (2000)
26. M. Clavaud, Y. Roggo, R. Von Daeniken, A. Liebler, J.-O. Schwabe, Chemometrics and inline near infrared spectroscopic monitoring of a biopharmaceutical Chinese hamster ovary cell
culture: Prediction of multiple cultivation variables. Talanta 111, 28–38 (2013)
27. Z. Sun, C. Li, L. Li, L. Nie, Q. Dong, D. Li, L. Gao, H. Zang, Study on feasibility of determination of glucosamine content of fermentation process using a micro NIR spectrometer.
Spectrochim. Acta Part A Mol. Biomol. Spectrosc. 201, 153–160 (2018)
28. J.G. Henriques, S. Buziol, E. Stocker, A. Voogd, J.C. Menezes, Monitoring mammalian cell
cultivations for monoclonal antibody production using near-infrared spectroscopy, in Optical
Sensor Systems in Biotechnology, ed. by G. Rao (Springer, Berlin, Heidelberg, 2009), pp. 29–72
29. A.P. Teixeira, R. Oliveira, P.M. Alves, M.J.T. Carrondo, Advances in on-line monitoring and
control of mammalian cell cultures: supporting the PAT initiative. Biotechnol. Adv. 27(6),
726–732 (2009)
30. M.S. Kamat, R.A. Lodder, P.P. DeLuca, Near-infrared spectroscopic determination of residual
moisture in lyophilized sucrose through intact glass vials. Pharm. Res. 6(11), 961–965 (1989)
31. A. Funke, R. Gross, S. Tosch, A. Tulke, Recent achievements in NIR-based on-line monitoring
of lyophilisation processes. Eur. Pharm. Rev. 21(3), 50–53 (2016)
32. D. Brouckaert, L. De Meyer, B. Vanbillemont, P.J. Van Bockstal, J. Lammens, S. Mortier,
J. Corver, C. Vervaet, I. Nopens, T. De Beer, Potential of near-infrared chemical imaging as
process analytical technology tool for continuous freeze-drying. Anal. Chem. 90(7), 4354–4362
(2018)
33. S. Pieters, T. De Beer, Y. Vander Heyden, Near-infrared and Raman spectroscopy: potential
tools for monitoring of protein conformational instability during freeze-drying processes. Am.
Pharm. Rev. 15(1), 2012
B. Igne and E. W. Ciurczak
15. European Medicine Agency, Guideline on the Use of Near Infrared Spectroscopy by the
Pharmaceutical Industry and the Data Requirements for New Submissions and Variations.
2014
16. United States Food and Drug Administration, Draft Guidance—Development and Submission
of Near Infrared Analytical Procedures Guidance for Industry. 2015
17. T. Miyano, H. Nakagawa, T. Watanabe, H. Minami, H. Sugiyama, Operationalizing maintenance of calibration models based on near-infrared spectroscopy by knowledge integration. J.
Pharm. Innov. 10(4), 287–301 (2015)
18. M. Hoehse, J. Alves-Rausch, A. Prediger, P. Roch, C. Grimm, Near-infrared spectroscopy in
upstream bioprocesses. Pharm. Bioprocess 3, 153–172 (2015)
19. R.W. Silman, L.T. Black, K. Norris, Assay of solid–substrate fermentation by means of
reflectance infrared analysis. Biotechnol. Bioeng. 25(2), 603–607 (1983)
20. J. Crowley, S.A. Arnold, N. Wood, L.M. Harvey, B. McNeil, Monitoring a high cell density
recombinant Pichia pastoris fed-batch bioprocess using transmission and reflectance near
infrared spectroscopy. Enzyme Microb. Technol. 36(5), 621–628 (2005)
21. M. Goldfeld, J. Christensen, D. Pollard, E.R. Gibson, J.T. Olesberg, E.J. Koerperick, K. Lanz,
G.W. Small, M.A. Arnold, C.E. Evans, Advanced near-infrared monitor for stable real-time
measurement and control of Pichia pastoris bioprocesses. Biotechnol. Prog. 30(3), 749–759
(2014)
22. N. Petersen, P. Odman, A.E. Padrell, S. Stocks, A.E. Lantz, K.V. Gernaey, In situ near infrared
spectroscopy for analyte-specific monitoring of glucose and ammonium in streptomyces
coelicolor fermentations. Biotechnol. Prog. 26(1), 263–271 (2010)
23. L.O. Rodrigues, L. Vieira, J.P. Cardoso, J.C. Menezes, The use of NIR as a multi-parametric
in situ monitoring technique in filamentous fermentation systems. Talanta 75(5), 1356–1361
(2008)
24. M.J. McShane, G.L. Coté, Near-infrared spectroscopy for determination of glucose, lactate,
and ammonia in cell culture media. Appl. Spectrosc. 52(8), 1073–1078 (1998)
25. C.B. Lewis, R.J. McNichols, A. Gowda, G.L. Coté, Investigation of near-infrared spectroscopy
for periodic determination of glucose in cell culture media in situ. Appl. Spectrosc. 54(10),
1453–1457 (2000)
26. M. Clavaud, Y. Roggo, R. Von Daeniken, A. Liebler, J.-O. Schwabe, Chemometrics and inline near infrared spectroscopic monitoring of a biopharmaceutical Chinese hamster ovary cell
culture: Prediction of multiple cultivation variables. Talanta 111, 28–38 (2013)
27. Z. Sun, C. Li, L. Li, L. Nie, Q. Dong, D. Li, L. Gao, H. Zang, Study on feasibility of determination of glucosamine content of fermentation process using a micro NIR spectrometer.
Spectrochim. Acta Part A Mol. Biomol. Spectrosc. 201, 153–160 (2018)
28. J.G. Henriques, S. Buziol, E. Stocker, A. Voogd, J.C. Menezes, Monitoring mammalian cell
cultivations for monoclonal antibody production using near-infrared spectroscopy, in Optical
Sensor Systems in Biotechnology, ed. by G. Rao (Springer, Berlin, Heidelberg, 2009), pp. 29–72
29. A.P. Teixeira, R. Oliveira, P.M. Alves, M.J.T. Carrondo, Advances in on-line monitoring and
control of mammalian cell cultures: supporting the PAT initiative. Biotechnol. Adv. 27(6),
726–732 (2009)
30. M.S. Kamat, R.A. Lodder, P.P. DeLuca, Near-infrared spectroscopic determination of residual
moisture in lyophilized sucrose through intact glass vials. Pharm. Res. 6(11), 961–965 (1989)
31. A. Funke, R. Gross, S. Tosch, A. Tulke, Recent achievements in NIR-based on-line monitoring
of lyophilisation processes. Eur. Pharm. Rev. 21(3), 50–53 (2016)
32. D. Brouckaert, L. De Meyer, B. Vanbillemont, P.J. Van Bockstal, J. Lammens, S. Mortier,
J. Corver, C. Vervaet, I. Nopens, T. De Beer, Potential of near-infrared chemical imaging as
process analytical technology tool for continuous freeze-drying. Anal. Chem. 90(7), 4354–4362
(2018)
33. S. Pieters, T. De Beer, Y. Vander Heyden, Near-infrared and Raman spectroscopy: potential
tools for monitoring of protein conformational instability during freeze-drying processes. Am.
Pharm. Rev. 15(1), 2012