AQbD Symposium - Day 2 - Developing Fit for Purpose Methods for the Complete Life Cycle

AQbD or Analytical Quality by Design is an 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 the enhanced approach.

Method development is step one, guaranteeing a quality assay requires stress testing and monitoring verified and validated methods. Learn how these easily implemented tools can help guarantee consistent quality and prevent unreliable results.

Join us on Wednesday, November 30 and hear from experts in the Pharma arena on the application of AQbD for compendial methods, how to apply Method performance monitoring, and application of AQbD in the European Pharmacopeia.

Followed by a live panel discussion with all the speakers. So have your questions ready!

Confirmed Speakers on 30 Nov:

AQbD principles application to compendial procedures and across the procedure life cycle

Presenter: Amanda Guiraldelli (Scientific Affairs Manager, US Pharmacopeia)

Amanda Guiraldelli has been with USP since 2012 and holds the position of scientific affairs manager. She is also the scientific liaison for the USP chapters <1220> Analytical Procedure Life Cycle and <1039> Chemometrics in the compendial science group-general chapters. Previously, Amanda worked as senior scientist at the USP reference standard laboratory for 8 years with characterization of compendial standards.She is visiting professor at the University of Campin as (UNICAMP) Brazil at the Institute of Chemistry and is a frequent speaker and instructor on topics related to analytical procedure life cycle and Analytical Quality by Design (AQbD). Amanda is specialist in chromatography, mass spectrometry and chemometrics and has more than 12 years of experience in pharmaceutical R&D areas.

Prior to joining USP, she was R&D scientist in a Brazilian pharmaceutical industry and visiting scientist at TU Berlin in Germany and Leiden University in Netherlands (Center for Proteomics and Metabolomics) working on proteins characterization by LC-HRMS and procedure development using UHPLC-HRMS. Amanda is graduated in pharmacy biochemistry and holds a Ph.D. in analytical chemistry from the University of São Paulo (metabolomics by UHPLC-HRMS, GC-MS and 1H NMR and chemometrics).

Replacement of a viral content method for a more robust anion exchange chromatography method

Presenter: Dawn Kernaghan (Principal Scientist, AstraZeneca)

Dawn received a Masters in Chemistry in 2002 from University of Maryland. After graduating, she got her first work experience in academia performing muscular dystrophy research. She joined AstraZeneca, formerly Medimmune, in 2006 where she worked in analytical method development. While in development shefocused in the areas of immunoassays, new technology evaluations and automation. In 2016, she moved into Operations where she now works on the validation and technology transfer of analytical methods for commercial.

Benefits of using 2.x µm columns on UHPLC systems for AQbD development

Presenter: Andrea Gheduzzi (Southern Europe Pharma Market Dev. Manager, Waters Corporation)

Andrea has spent more than 30 years in the chromatography field. Across his career he had various roles, service engineer, chromatography lab position, and technical application support manager. He has mainly been dealing with pharma accounts, also supporting LC method development activities using DoE/QbD approaches. In his role as Pharma Business Development Manager at Waters he has further expanded his expertise in AQbD and related applications.

Moderator for the Event Day 2

Presenter: Arjan Timmerman (Waters Corporation)