Waters LC Symposium - Pharma

From the everyday consumer to scientists in the laboratory, we all rely on accurate information to make critical decisions.

Waters Corporation is pleased to bring together chromatography thought leaders for a week of scientific talks, live demonstrations, panel discussions, and networking regarding novel liquid chromatography technologies and applications.

Join us for this virtual symposium beginning with a plenary session on Monday, March 22nd and followed by application sessions for Pharma, Food, Materials and Biomedical Research throughout the week!

TUESDAY, MARCH 23, 2021

Morning Session Only - 5:00 - 6:30pm CET

Addressing Challenges of Forced Degradation Studies

We are addressing studies that are integral to ensuring patient safety, evaluating the specificity of stability indicating methods, and assessing the impurities & degradants related to a formulation and drug substance. Forced degradation studies are vital for developing a new small molecule drug. These studies play an important role in the development of analytical methods, setting specifications, and designing the formulation of a new therapeutic. Join us to hear from chemists performing these studies and about new practical tools for completing these key studies.

Presentations:

1. Access Accurate Mass with a SmartMS Enabled Mass Detector for Forced Degradation Studies (Chris Henry, Waters Corporation)

Presenter: Chris Henry (Senior Scientist, Waters Corporation)

Chris has been at Waters for 8 years working in the area of small molecule pharma solutions using LC-MS. Prior to joining Waters Chris has worked in industry for ~20years focussing on late-stage development and QC. He obtained a degree in Biochemistry from the University of Paisley.

2. Stability Indicating LC Method Optimization with Fusion QbD PeakTracker

Presenter: Joe Turpin (Director, Chromatography Products & Services, S-Matrix)

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.

3. Pragmatic Considerations and Practical Approaches for Forced Degradation in Method Validation

Presenter: James French (Sr. Scientist, Team Lead, Eurofins BioPharma Product Testing)

30+ years in the pharmaceutical industry. 10 years in bulk pharmaceutical research and quality management. 10 years in performing laboratory / quality management contract manufacturing for animal health products and 10 years in managing multiple groups in a contract research organization supporting cGMP method development and validation. Bachelor’s of Science was earned from the University of Missouri in St. Louis.

4. Panel Discussion - What is the future of impurities method development and forced degradation?

Moderated by: Andrew Leightner (Market Development Manager, DMPK, Discovery, E&L, Waters Corporation)

Andy Leightner is a Market Development Manager at Waters Corporation for the past year and a half. Prior to Waters, Andy worked for many clients as part of Contract Research Organizations. He focused on solving the challenging needs associated with method development and validation. Andy earned a degree in biology from The University of Wisconsin – Madison.