When Good Analytical Methods Become a Problem

An analytical method does not have to fail to become a problem. As biopharmaceutical programs progress, established methods can become harder to reproduce, transfer, scale, or maintain, while regulatory expectations, operational demands, and available technologies continue to evolve.

In this webinar, explore the factors that can signal it is time to reassess an existing method.

Drawing on practical examples and supporting data, our speaker will examine how scientific performance, standardization, workflow considerations, and lifecycle planning can inform method-change decisions, helping analytical development and quality control (QC) teams determine the most appropriate path forward.

Attend this webinar to:

• Explore opportunities to improve analytical workflows as testing needs and technologies evolve
• Identify when it may be beneficial to reassess an analytical method as product, process, and testing requirements evolve
• Understand how variability, method transfer, workflow demands, and evolving technology can affect methods as they progress from development through validation and routine QC
• Explore key considerations that can influence analytical method changes across different stages of the product lifecycle

Presenter: Ilaria Scarfone, PhD (Senior Field Application Scientist, Thermo Fisher Scientific)

Dr. Ilaria Scarfone is a field application specialist in Thermo Fisher Scientific's pharma analytics team, a role she has held since September 2019. She currently lives in Pisa and supports clients in South West Europe. Ilaria completed her PhD in industrial biotechnology at the University of Milan in collaboration with the Cell Biology Research Center of Montpellier and subsequently spent two years as a postdoctoral researcher at the Grenoble Atomic Energy Commission. In addition to her academic research background, Ilaria earned a master’s in business and administration from the Institut d'Administration des Entreprises in Montpellier in 2018, before joiningThermo Fisher Scientific as a technical specialist for the pharma analytics portfolio.