Using the Analytical Target Profile (ATP) for Efficient Procedure Lifecycle Management

The ATP outlined in the USP <1220> and ICH guideline Q14 serves as a crucial component in the lifecycle management of analytical procedures, connecting various stages to ensure procedure fitness for use. 

This presentation will explore the key role of the ATP in determining analytical procedure attributes and performance criteria, guiding procedure design, validation, and facilitating ongoing procedure performance and continual improvement of procedure. 

Strategies for establishing ATP performance requirements will be discussed, alongside case studies showcasing how the ATP and an enhanced approach facilitate technology change, post-approval changes and enable the adoption of analytical platform concepts across diverse product classes. The presentation will also explore the risk-based approach outlined in ICH Q14 for identifying established conditions and reporting categories for post approval changes, enhancing the understanding and implementation of ATP-driven methodologies in pharmaceutical development.

Presenter: Amanda Guiraldelli (Senior Scientist, Proteins and Oligonucleotides Analytics, RIC Group, Belgium)

Senior Scientist, Proteins and Oligonucleotides Analytics, RIC Group, Belgium , she specializes in proteins and oligonucleotides analytics at the CRO Research Institute for Chromatography Group (RIC Group) in Belgium. As a subject matter expert in biopharmaceutical analysis, she provides technical guidance on the development and validation of analytical procedures for release testing, stability studies, and characterization of biological products, while supporting ICH Q14 and AQbD-driven strategies to enhance procedure performance, collaborating with key biopharma partners.

With over a decade of experience at the United States Pharmacopeia (USP), Amanda served as scientific affairs manager and scientific liaison contributing to the development of USP standards, including USP <1220> on analytical procedure lifecycle, and led cross-functional initiatives to implement AQbD-driven procedure development strategies, including DoE and predictive modeling, and genotoxic trace impurities analysis, collaborating with USP’s labs, industry partners, and global regulatory bodies. Previously, Amanda worked for 8 years as a Senior Scientist at the USP Reference Standard Laboratory and as a visiting scientist at TU Berlin and Leiden University focusing on LC-HRMS-based protein characterization and method development.

She is an expert in chromatography and mass spectrometry (MS) applied to small and large molecule characterization, a frequent conference speaker, and mentor of students on AQbD-related projects at the University of Campinas (UNICAMP), Brazil. Amanda holds a Ph.D. in Analytical Chemistry from the University of São Paulo with a focus on MS-based metabolomics and chemometrics, and a B.Sc. in Pharmacy and Biochemistry.