Chapter 12
Method Development
Benoît Igne , Gary McGeorge , and Zhenqi Shi
Abstract A general framework for method development based on the analytical
quality by design process is presented and applied to the development of near-infrared
spectroscopic methods. The framework is particularly well suited to secure stakeholder alignment, setting appropriate expectations and ensuring that resources are
spent appropriately. After setting method goals and expectations and confirming
feasibility, a risk assessment is performed to identify all the factors that could affect
the method. The method is then developed with the intention to mitigate the impact
of those risks. The result is a robust method that can be tested and validated if
required by the regulatory environment of use. Aspects of method lifecycle are also
discussed as method development is only a part of the process of successfully using
near-infrared spectroscopic methods in routine commercial applications. Aspects
of interface to the process, sample set selection, model optimization, system suitability, and performance monitoring are discussed in the context of building robust
methods. The analytical quality by design framework can significantly streamline
method development and lifecycle management efforts to ensure a successful deployment and long-term value generation from a NIR spectroscopic method. Continuous
improvement ensures method performance over the useful life of the method.
Keywords Near-infrared spectroscopy · Analytical quality by design · Method
development · Method lifecycle
B. Igne (B)
Vertex Pharmaceuticals Inc, 50 Northern Avenue, Boston, MA 02210, USA
e-mail: Benoit_Igne@vrtx.com
G. McGeorge
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08901, USA
e-mail: gary.mcgeorge@bms.com
Z. Shi
Eli Lilly and Company, Indianapolis, IN 46285, USA
e-mail: shi_zhenqi@lilly.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_12
277
Method Development
Benoît Igne , Gary McGeorge , and Zhenqi Shi
Abstract A general framework for method development based on the analytical
quality by design process is presented and applied to the development of near-infrared
spectroscopic methods. The framework is particularly well suited to secure stakeholder alignment, setting appropriate expectations and ensuring that resources are
spent appropriately. After setting method goals and expectations and confirming
feasibility, a risk assessment is performed to identify all the factors that could affect
the method. The method is then developed with the intention to mitigate the impact
of those risks. The result is a robust method that can be tested and validated if
required by the regulatory environment of use. Aspects of method lifecycle are also
discussed as method development is only a part of the process of successfully using
near-infrared spectroscopic methods in routine commercial applications. Aspects
of interface to the process, sample set selection, model optimization, system suitability, and performance monitoring are discussed in the context of building robust
methods. The analytical quality by design framework can significantly streamline
method development and lifecycle management efforts to ensure a successful deployment and long-term value generation from a NIR spectroscopic method. Continuous
improvement ensures method performance over the useful life of the method.
Keywords Near-infrared spectroscopy · Analytical quality by design · Method
development · Method lifecycle
B. Igne (B)
Vertex Pharmaceuticals Inc, 50 Northern Avenue, Boston, MA 02210, USA
e-mail: Benoit_Igne@vrtx.com
G. McGeorge
Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08901, USA
e-mail: gary.mcgeorge@bms.com
Z. Shi
Eli Lilly and Company, Indianapolis, IN 46285, USA
e-mail: shi_zhenqi@lilly.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_12
277