AQbD Symposium - Day 2 - AQbD Enhanced Method Development

AQbD or Analytical Quality by Desgin is a new approach to analytical method development that “starts with the end in mind”.

Exploring experimental conditions and using statistical tools to search for a suitable set of conditions until the method is stable and quality goals are met, are the key success factors for this enhanced approach.

Regulators welcome this science and risk-based approach as described in several upcoming guidelines from ICH, USP, and BP.

Using the preferred language of regulators when filing applications for both small and large molecules, synthetic or biological drugs can significantly reduce the time-to-market.

Join us on Monday, November 29th and hear from many experts in the Pharma arena on how to increase your knowledge around the analytical procedure and minimize the risk of OOS results.

Day 2 - AQbD Enhanced Method Development

Developing an analytical procedure with “the end in mind” can be successfully obtained by applying a structured and systematic approach. New chromatographic statistical software which connects directly to Empower greatly simplifies the workflow while keeping data integrity intact. A suitable replication strategy simplifies the intrinsically robust procedure developed using QbD tools to ensure it meets the goals of the ATP.

15:05 –15:25 (CET): Knowledge Improvement Obtained by Applying AQbD to an Impurity Profile Method

Presenter: Justine Lenglet (Responsible for development and validation of analytical methods, Minakem)

Justine studied at the chemistry school in Strasbourg in France, there she specialized in analytical chemistry. She ended her studies with a 6monthsproject in Sanofi Pasteur where she worked onthecharacterizationof glycoconjugate by HPSEC. Then she workedat SanofiChimieand now it hasbeen two yearssince she worked at Minakem Recherche asanAnalytical R&D Scientist. She is responsible for the development and validation of the analytical methods.

Presenter: Maxime Lille (Ingénieur analytique, Minakem)

Pharmacist, I have done my studies in Clermont-Ferrand, France. During these studies I did internships in various fields and structures. I first worked on the prediction of drug-drug interaction in the King’s college of London before doing an internship in a start-up, LX repair, that develop kit to detect resistance to cancer treatment. Then, I worked in an hospital on the method development to analyse metabolites in urine matrix. I then graduated as a chemistry engineer in Sigma-Clermont and did a final internship in Sanofi Vertolaye in the production support department before integrating Minakem where I work as an analytical engineer since a year.  

15:25 –15:45 (CET): AQbD Method Development for Large Molecules: IEX of Antibodies

Presenter: Szabolcs Fekete (Research & Development, Waters)

Szabolcs Fekete worked in the pharmaceutical industry for 10 years, then, moved to the University of Geneva in Switzerland and worked as a scientific collaborator for another decade. In April 2021, he joined Waters Corporation and now works as a consulting scientist. He published more than 150 peer reviewed journal articles and contributed to book chapters and handbooks.

15:45 –16:05 (CET): Definition of a Suitable Replication Strategy to Meet ATP

Presenter: Gérald de Fontenay (Cebiphar, Scientific and Technical Director)

Gérald worked in different analytical services providers and CDMOs for more than 25 years.Today, as Scientific and Technical Director at Cebiphar, he continues his quest to guarantee that data coming from the laboratories are reliable. He brings his expertise in validation, verification, and transfer of analytical methods to the analytical project managers and to the customers from Cebiphar, in order to conclude successfully the projects manager by Cebiphar.

16:05 –16:30 (CET): Live Q&A with all Panelists

Moderator: Alec Kettle (Pharmaceutical Field Marketing Manager Europe, Waters)