Analytical Quality by Design: Eurofins BPT France delivers new level of expertise for methods development
Marjorie Boscus, Study Manager, Analytical Development, marjorieboscus@eurofins.com; Alexandra Belveze, Analytical Development and Validation Projects Team Leader, alexandrabelveze@eurofins.com; Eurofins Amatsi Analytics France
Analytical method development has always been a crucial issue for biopharmaceutical industry. How can we develop fast, efficient, and robust methods to support biopharmaceutical products during their whole lifetime? From pre-clinical studies to routine analysis, Analytical Quality by Design is the answer to this challenge.
ICH Q14 (revision of ICH Q2 (R1) publication is planned for 2021 and will describe the concept of Quality by Design within the framework of analytical development. In order to provide customers with a full experience of method development and the most up-to-date support, Eurofins Amatsi Analytics, Fontenilles, France, has dedicated a team of experts since 2013 for AQbD method development.
Thanks to Design of Experiment (DoE), AQbD strategy allows screening of various critical parameters for HPLC method development. Up to 4 columns, 6 aqueous mobile phases, 2 organic solvents and 3 gradient times can be evaluated at the same time. In comparison with the classical OFAT (One Factor at A Time) approach, AQbD establishes a very wide knowledge base in a reduced time as it assesses interactions between the tested parameters. Thus the best parameters for clients’ methods can be defined.
Fusion QbD® (S-Matrix) is the software used at Eurofins Amatsi Analytics to perform DoE and process the generated data; the whole statistics treatment is fast and seamless. Thanks to peak counting, Eurofins is able to determine which tested conditions are the most suitable for the method. Moreover, simulated robustness can be performed to improve method lifecycle and risk assessment. This software is directly connected to Empower3 with a UPLC system equipped at Eurofins Amatsi Analytics. The last version (9.9.0) has been acquired in 2020 and allows dynamic visualisation of the best chromatographic profile and elution conditions.
AQbD is a powerful tool to obtain robust analytical methods that will help biopharmaceutical projects to advance further and improve lifecycle management. For more information visit: www.eurofins.fr/pharma/accueil/