Selection of Analytical Technology and Development of Analytical Procedures Using the Analytical Target Profile.
Phil Borman1, Cristiana Campa2, Ghislain Delpierre3
1Product Development and Supply, GSK, Medicines Research Centre, Gunnels Wood Road, Stevenage SG1 2NY, U.K.
Analytical Chemistry
|December 20, 2021
Summary
A structured analytical method development approach ensures robustness. Defining the analytical target profile (ATP) guides technology selection and procedure evaluation for optimal analytical methods.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Sciences
Background:
- Analytical procedures require robustness throughout their lifecycle.
- The analytical target profile (ATP) defines the required quality of a reportable value.
- Selecting appropriate analytical technology is crucial for method development.
Purpose of the Study:
- To outline a structured approach for analytical method development.
- To demonstrate the application of the analytical target profile (ATP) in selecting analytical procedures.
- To evaluate analytical procedures against business drivers for suitability.
Main Methods:
- Utilizing the analytical target profile (ATP) to guide technology selection.
- Screening potentially fit-for-purpose analytical procedures.
- Evaluating selected procedures against business drivers and operational constraints.
- Case studies across small molecules, vaccines, and biotherapeutics.
Main Results:
- The ATP facilitates the selection of suitable analytical technologies and procedures.
- Case studies illustrate diverse aspects of method selection, including platform approaches and multi-attribute procedures.
- Analytical technologies can inform product characterization for ATP definition or refinement.
- Challenges include pharmacopoeial monographs linking acceptance criteria to specific technologies.
Conclusions:
- A structured approach, guided by the ATP, enhances analytical procedure robustness and suitability.
- Method selection should integrate technical requirements (ATP) with business drivers.
- Flexibility in method development is key, especially when addressing pharmacopoeial constraints.
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