Analytical Quality by Design: from Quality Target Product Profile to the Analytical Target Profile
Key Learning Outcomes
- Learn how the Analytical Target Profile (ATP) serves as a forward-looking framework for defining performance criteria such as robustness, accuracy, precision, and quantitation limits, thereby guiding the development of analytical procedures from the outset.
- Understand how Analytical Quality by Design (AQbD) functions as a risk management strategy, allowing for the definition of a Method Operable Design Region (MODR) that ensures overall analytical quality with minimal risk of failure.
- Discover how the structured development approach of ICH Q14 applies to both small molecules and biopharmaceuticals, with practical ATP examples covering identity, impurity profiling, charge heterogeneity, and primary structure determination.
- Explore how multivariate tools, including screening designs, response surface studies, and Monte Carlo simulation, support risk-based method development and the establishment of proven acceptable ranges.
Event Overview
This presentation by Prof Sandra Furlanetto examines the application of Analytical Quality by Design and highlights the central role of the Analytical Target Profile in developing fit-for-purpose analytical procedures in accordance with ICH Q14 guidance. We will explore how AQbD shifts method development from trial-and-error to a rational, knowledge-driven process, one that defines performance expectations before development begins and upholds them throughout the entire procedure lifecycle.
The session explains how the ATP is built for different drug types, from small molecule impurity profiling to biopharmaceutical charge variant analysis, and how performance criteria like total analytical error, bias, and relative standard deviation are used to establish clear, measurable targets. A practical example with duloxetine and its seven impurities demonstrates how a complete ATP is defined, including selectivity, limits of quantitation, working range, and accuracy standards.
Sandra then walks through a multivariate, risk-based development workflow: starting with hazard identification using Ishikawa diagrams and cause-and-effect matrices, progressing through screening and optimisation designs, and culminating in the statistical definition of the method operable design region. Throughout, the session demonstrates how design of experiments provides objective, model-based understanding of analytical procedures, reducing subjectivity and enhancing regulatory defensibility.
Who Should Attend?
Anyone involved in analytical method development, quality control, or regulatory strategy aiming to apply the ICH Q14 framework to develop more robust, lifecycle-ready analytical procedures.
- Analytical Scientists and Method Development Chemists
- Quality Control and Quality Assurance Professionals
- Regulatory Affairs and CMC Submission Specialists
- Biopharmaceutical and Small Molecule Development Teams
- Validation and Compliance Scientists
- R&D and Technical Operations Managers overseeing analytical functions
Unlock Additional Educational Resources
Register today for Sandra’s presentation and gain access to exclusive bonus content, such as the insightful panel discussions on “Overview of the ICH Q14 Guideline” and “Key Challenges and Solutions in Implementing ICH Q14”.
Prof. Sandra FurlanettoProfessor of Analytical ChemistryUniversity of Florence (Italy)Prof. Sandra Furlanetto holds a PhD in Pharmaceutical Chemistry and is a Full Professor of Analytical Chemistry at the University of Florence. She serves as the Editor of the Journal of Pharmaceutical and Biomedical Analysis and is a member of the Italian National University Council. From 2011 to 2021, she acted as the Rector’s Delegate for student guidance at the University of Florence. She has made significant contributions to the dissemination, both nationally and internationally, of the role played by multivariate strategies in analytical chemistry and pharmaceutical technology. She is an expert in applying QbD and AQbD to ensure the quality of analytical processes and pharmaceutical products.
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