Chapter 18
Near-Infrared Spectroscopy
in the Pharmaceutical Industry
Benoît Igne and Emil W. Ciurczak
Abstract Since the first applications of near-infrared spectroscopy in the pharmaceutical industry to today’s in-line and in real-time monitoring and control of manufacturing processes, the technology has come a long way in sensitivity, robustness,
and deployability. The pharmaceutical industry is now able to rely on the technology
to release medicine to patients without having to sample for off-line analyses. The
sensitivity of NIR light to the matrix, which makes it a tool of choice for raw material
identification and counterfeit detection, can be an issue for quantitative and qualitative methods as much of the variance has to be captured by the model prior to
validation to avoid repeated method updates. Nevertheless, its flexibility of implementation, hardware ruggedness, and wide range of applicability makes it a tool
of choice for process understanding, monitoring, and control. In this chapter, an
overview of the current usage is provided for the development, understanding, and
control of pharmaceutical processes for small molecule drug substances, drug products, and biopharmaceutical materials. A discussion of the regulatory environment
and available guidance documents is provided. Finally, the intended method use
and the associated method validation requirements are discussed in the context of
building fit for purpose methods.
Keywords Near-infrared spectroscopy · Pharmaceutical · Drug substance · Drug
product · Biopharmaceutical
B. Igne (B)
Vertex Pharmaceuticals Inc, 50 Northern Avenue, Boston, MA 02210, USA
e-mail: Benoit_Igne@vrtx.com
E. W. Ciurczak
Doramaxx Consulting, 77 Park Road, Goldens Bridge, NY 10526, USA
e-mail: emil@ciurczak.com
© Springer Nature Singapore Pte Ltd. 2021
Y. Ozaki et al. (eds.), Near-Infrared Spectroscopy,
https://doi.org/10.1007/978-981-15-8648-4_18
391
Near-Infrared Spectroscopy
in the Pharmaceutical Industry
Benoît Igne and Emil W. Ciurczak
Abstract Since the first applications of near-infrared spectroscopy in the pharmaceutical industry to today’s in-line and in real-time monitoring and control of manufacturing processes, the technology has come a long way in sensitivity, robustness,
and deployability. The pharmaceutical industry is now able to rely on the technology
to release medicine to patients without having to sample for off-line analyses. The
sensitivity of NIR light to the matrix, which makes it a tool of choice for raw material
identification and counterfeit detection, can be an issue for quantitative and qualitative methods as much of the variance has to be captured by the model prior to
validation to avoid repeated method updates. Nevertheless, its flexibility of implementation, hardware ruggedness, and wide range of applicability makes it a tool
of choice for process understanding, monitoring, and control. In this chapter, an
overview of the current usage is provided for the development, understanding, and
control of pharmaceutical processes for small molecule drug substances, drug products, and biopharmaceutical materials. A discussion of the regulatory environment
and available guidance documents is provided. Finally, the intended method use
and the associated method validation requirements are discussed in the context of
building fit for purpose methods.
Keywords Near-infrared spectroscopy · Pharmaceutical · Drug substance · Drug
product · Biopharmaceutical
B. Igne (B)
Vertex Pharmaceuticals Inc, 50 Northern Avenue, Boston, MA 02210, USA
e-mail: Benoit_Igne@vrtx.com
E. W. Ciurczak
Doramaxx Consulting, 77 Park Road, Goldens Bridge, NY 10526, USA
e-mail: emil@ciurczak.com
© Springer Nature Singapore Pte Ltd. 2021
Y. Ozaki et al. (eds.), Near-Infrared Spectroscopy,
https://doi.org/10.1007/978-981-15-8648-4_18
391