Overview of the GC Orbitrap Technology and Its Application to Extractables & Leachables in Medical Devices or Pharmaceutical Products

Part 1: Alex Makarov briefly introduces the GC Orbitrap technology and how its design supports a wide range of analytical applications, such as environmental, food safety, metabolomics, and pharmaceutical.

Part 2: Migration of compounds from one medium to another imposes a lot of issues on product quality, impacts regulation, and impairs product safety. The extent of compound migration has to be monitored per certain standards. There are techniques or programs implemented/established in industries to monitor and test for component migration, otherwise called extractables and leachables (E&L).

These test requirements or programs for monitoring E&L compounds are well established for pharmaceutical products, medical devices, food packaging, semiconductor materials, and biotechnology products. The techniques for testing are established to detect and identify hundreds of compounds, however, a common challenge still exists in toxicology assessment because many compounds detected cannot be identified or verified.

In this talk, Ekong Bassey will describe a workflow that utilizes the Thermo Scientific™ Orbitrap™ GC-MS system to screen, detect, identify, and characterize E&L compounds.

Presenter: Alexander Makarov, Ph.D. (Director Global Research LSMS, Thermo Fisher Scientific)

Alexander Makarov was born in the Siberian town of Irkutsk in 1966 and went to study at the Moscow Engineering Physics institute where he also obtained his Ph.D. After 2 post-doc years at Warwick University, he joined HD Technologies, a small high-tech company in Manchester (UK) where he started his work on the Orbitrap mass analyzer. Following the acquisition of the firm by Thermo Electron Corp. in 2000, Alexander provided scientific leadership of Orbitrap R&D, which led to the commercial launch of LTQ Orbitrap mass spectrometer in 2005 and subsequent extensions and new generations of this technology.

He has received multiple awards, including the ASMS Award for Distinguished Contribution in Mass Spectrometry and the Thomson medal of IMSF. He holds the position of Director of Research, Life Science Mass Spectrometry, in Bremen, Germany and Chair in High Resolution Mass Spectrometry at Utrecht University in Netherlands. He was elected a Fellow of the Royal Society (FRS) in 2020.

Presenter: Ekong Bassey (Application Scientist, Thermo Fisher Scientific)

Ekong Is an Applications Scientist and an Integral member of the Thermo Fisher Scientific Center Of Excellence. In his role, he is focused on developing Orbitrap GC applications and integrated workflow solutions. He also supports the sales team by interfacing with both internal and external customers