Panel Discussion: Making Instrument Equivalency Assessments and Actions Successful

Pharmaceutical companies are known for being reluctant to change instrument equipment or instrument vendors as this requires substantial efforts for qualification and associated documentation, as well as training activities. Consequently, many pharma companies use conventional HPLC methods for commercial product release, and UHPLC methods are not common in Pharma industry.

Considerations for method transfer from conventional HPLC to UHPLC techniques are also discussed.

With all new equipment in the laboratory, our Pharma CDMO services faced many questions from sponsors. We discuss how performance differences can be counterbalanced and productivity improved with due diligence in method transfer and instrument equivalency procedures. As an example, we highlight the case of transferring an existing validated small molecule drug analysis method to Thermo Scientific Vanquish Flex UHPLC system.

This session includes short presentations from our panelists, and a panel discussion. You'll also have the opportunity to ask your questions from the experts in the panel.

Presenter: Sergey Vinogradov (R&D Scientist II, at PDS Analytical Development, Pharma Services Group Patheon, Thermo Fisher Scientific)

Sergey Vinogradov is an analytical chemist and chromatography subject matter expert. He has been an HPLC and chromatography trainer for the last 5 years, and has extensive experience in both method development and troubleshooting. He holds a Master’s degree in Analytical Chemistry from East Carolina University, and is currently working at the Thermo Fisher Scientific Pharma Services, Greenville, N.C. site as an R&D Scientist II.

Presenter: Michael L. Harris (Director, QC, Thermo Fisher Scientific)

Michael L. Harris is the QC Director for the Thermo Fisher Scientific Pharma Services Greenville, NC facility. He oversees labs responsible for commercial release, stability, and raw material testing, as well as supporting method transfer activities into the site. His labs support both the steriles as well as oral solid dose business units. He also oversees microbiological labs that perform release testing as well as analytical development.

Prior to joining Thermo Fisher Scientific Pharma Services in 2017, Michael worked in analytical laboratory functions for Wyeth, Schering-Plough, Teva, and Mallinckrodt Pharmaceuticals.

Michael attended the University of Arkansas, with a BS in Chemistry.

Presenter: Bill Weiser, Ph.D. (Sr. Director, Global Quality systems, Pharma Services Group Patheon, Thermo Fisher Scientific)

William (Bill) E. Weiser, Ph.D., is Senior Director, Global Quality Systems, part of Global Quality Assurance in the Pharma Services - Thermo Fisher Scientific. He is currently leading a centralized function to globally support the 50 Pharma Services, Thermo Fisher Scientific sites with Quality Assurance Systems, Compliance, Quality Operations, Laboratory Systems & Technology, Supplier Quality Management, Digital Quality Systems, and a Quality Academy. During his tenure at Patheon/Thermo Fisher Scientific, he has been responsible for global leadership of Analytical Development Strategies, Laboratory Informatics, and chromatographic instrumentation deployment.

Weiser’s previous appointments include General Manager of the Pharmaceuticals Division of Liquidia Technologies, Inc., and Vice President Analytical Chemistry at Cardinal Health/Magellan Laboratories.

Weiser earned a Ph.D. in analytical chemistry from Purdue University, West Lafayette, IN, and he is active in the American Association of Pharmaceutical Scientists, having been elected Treasurer in 2015. Within the AAPS, he has chaired the Publications, Program Coordination, and Annual Meeting Program Committees. He was elected to the leadership of the Analysis and Pharmaceutical Quality (APQ) section.

Presenter: Eric Grumbach (Director, Vertical Marketing, Chromatography and Mass Spectrometry, Analytical Instrument Group, Thermo Fisher Scientific)

Eric Grumbach has over 20 years of leadership at the intersection of science and business with expertise in strategic planning, product management, product marketing, and cross-functional leadership within the pharmaceutical market. He has extensive experience in reversed-phase and HILIC method development, chromatographic theory, and analytical method transfer. Eric is currently the Director of Pharma and Biopharma Marketing for Chromatography and Mass Spectrometry at Thermo Fisher Scientific.

Presenter: Dr. Frank Steiner (Sr. Manager of Product Applications and Scientific Advisor, Chromatography and Mass Spectrometry, Analytical Instrument, Thermo Fisher Scientific)

Dr. Frank Steiner is Sr. Manager of Product Applications and Scientific Advisor in the HPLC organization of Thermo Fisher Scientific and coordinates scientific collaborations with external partners to advance UHPLC technologies and applications. Frank received his Ph.D. degree in Chemistry in 1995 from Prof. Dr. Heinz Engelhardt at the Saarland University in Saarbrücken, Germany. He then became a postdoctoral research fellow at the CEA, Saclay in France focusing on elementary and isotopic analysis by IC and IC-ICP/MS in 1996. Frank returned to Saarland University in 1997 to conduct research on electro-driven separation techniques and became an assistant professor in 2003. In 2005 Frank joined the Dionex Softron GmbH in Germering, Germany, now a part of Thermo Fisher Scientific and conducted different roles in marketing before he became scientific advisor.