AQbD Symposium - Day 4 - Forced Degradation Studies: The Role of AQbD and Exact Mass

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 4 - Forced Degradation Studies: The Role of AQbD and Exact Mass

Developing a robust Stability Indicating Method is a critical factor for properly studying long term stability. Applying the AQbD enhanced approach during preliminary accelerated degradation experiments equips us well for properly setting suitable stability terms. Combining the AQbD knowledge with structural information of unknown degradation products using exact mass spectrometry provides a set of new techniques previously not readily available to all pharma scientists.

15:05 –15:25 (CET): QbD Development of a Stability Indicating Method using Forced Degradation Study Automation and MS Peak Tracking

Presenter:Joe Turpin (Director of Chromatography Products and Services, S-Matrix Corporation)

Joseph Turpin is Director of Chromatography Products and Services for S-Matrix Corporation. Mr. Turpin was formerly a Senior Research Scientist with Eli Lilly and Company in Indianapolis.A graduate of Purdue University and Indiana University, Mr. Turpin has long been engaged in drug product research and development, and the application of analytical technology in support of new drug development. Mr. Turpin has been involved with pharmaceutical drug development for over 30 years, including the development of several currently marketed products. Current research activities involve the application of Quality by Design (QbD) and experimental design (DOE) in support of new drug development.

15:25 –15:45 (CET): Stability-Indicating Method Development (UHPLC-UV) using AQbD principles

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

Dr. Amanda Guiraldelli is graduated in pharmacy biochemistry and holds a Ph.D. in analytical chemistry from the University of São Paulo - Brazil. Focus of her thesis was plant metabolomics by UHPLC-HRMS, GC-MS and1H NMR and application of QbD principles in analytical procedure development. Currently, Dr. Amanda Guiraldelli is scientific affairs manager at U.S. Pharmacopeia and visiting professor at the Federal University of Campinas (Unicamp) at the Institute of Chemistry mentoring students in research projects on AQbD. Amanda is specialist in chromatography and mass spectrometry and has 12 years of experience in R&D areas, with strong expertise in analytical procedure development & validation, AQbD, stability studies of drug products, analysis of pharmaceutical impurities & degradation products, chemometrics, omics science and characterization of compendial standards. Previously, Dr. Amanda Guiraldelli worked as senior scientist at the USP reference standard laboratory for 8 years with characterization of compendial standards. She also worked as R&D scientist in a brazilian pharmaceutical industry and as visiting scientist at Technishe Universität Berlin in Germany working on proteins characterization by LC-HRMS and at Leiden University in Netherlands (Center for Proteomics and Metabolomics) working on method development for characterization of biological samples by UHPLC-HRMS. Dr. Amanda Guiraldelli is also a member of the North Jersey Chromatography Group (NJCG) - American Chemical Society (ACS).

15:45 –16:05 (CET): Access Accurate Mass with a SmartMS Enabled Mass Detector for Forced Degradation Studies

Presenter:Chris Henry (Senior Scientist, Waters Corporation)

I spent 20 years in industry focusing on LC-MS solution for small molecule pharma in late stage development and QC. I joined Waters Scientific Operations divison based in the UK in 2013 where I have continued developing applications in this area.

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

Moderator: Arjan Timmerman (Waters Marketing Manager, Pharma EMEA, Compliance and Impurities)