We’re pleased to announce that we will be presenting at the Pharma ED Extractables & Leachables Summit 2026 in Providence, Rhode Island this April 22-23 at the Omni Hotel.
Summit focus: Quality, Safety, Biocompatibility & Regulatory Compliance for Drugs, Biologics, & Med Devices
Join our presentation!
When: Thursday, April 23, 2026, 8:15am to 8:55am
Title: A Strategic Framework to De Risk Unidentified Critical Issues—Non-targeted Analysis of Organic Extractables & Leachables
Abstract:
Non-Targeted Analysis (NTA) of organic extractables using orthogonal and complementary chromatographic methods often reveals compounds that cannot be conclusively identified, raising concern that some unknowns may belong to highly potent toxicological groups such as ICH Q3E Class 1 substances or broader Cohorts of Concern (CoC). To address the uncertainty surrounding unidentified compounds, Nelson Labs developed a structured three phase framework designed to systematically de risk the possibility that such unknowns belong to a CoC class.
In Phase 1, Nelson Labs defined 12 CoC structural classes relevant to extractables and leachables drawing on international regulatory standards and scientific guidance to establish a clear alert framework.
Phase 2 focused on direct identification using empirical data. Nelson Labs analyzed authentic reference standards for approximately 90 frequently encountered CoC compounds, selected to represent the full range of the 12 structural classes. For each compound, mass spectra, retention times, and Relative Response Factors (RRFs) were experimentally determined and compiled into the Nelson Database. This enables accurate identification and semi-quantification of these CoC compounds whenever they appear in NTA datasets, ensuring high-confidence characterization of known high-risk analytes.
Phase 3 expanded the safety net beyond these 90 substances. Using SciFinder, Nelson Labs identified the 100 most frequently reported compounds within each CoC class, using publication frequency as a proxy for relevance. Cross checking these compounds with NIST and WILEY mass spectral libraries showed that more than 600 CoC compounds are already represented in these commercial databases. When these libraries are included in NTA workflows, many additional CoC compounds become identifiable. Furthermore, applying RRF
data from the Nelson Database across related classes allows conservative assessment of these compounds at or above the analytical evaluation threshold (AET).
Although absolute certainty is unattainable, this three-phase framework provides a robust scientific basis for minimizing the likelihood that unidentified extractables are unrecognized CoC compounds, thereby strengthening the safety evaluation of medical device extracts.
For more information on the conference, please click here
Presenter: Philippe Verlinde, PhD, Senior Technical Advisor, Nelson Labs
Biography
Philippe Verlinde, PhD, is a Senior Technical Advisor at Nelson Labs Europe. With over 20 years of experience in trace analysis and pharmaceutical analytical research his current role is supporting Nelson Labs in providing best-in-class and innovative scientific services to the pharmaceutical and medical device industry with a focus on extractables and leachables (E&L) studies. Prior to joining the company (formerly Toxikon Europe) in 2013, Dr. Verlinde worked as a scientific support officer at the Institute for Reference Materials and Measurements (IRMM) of the European Commission’s Joint Research Centre contributing to metrological and standardization efforts in the context of regulatory related trace analysis. He holds a PhD in Bioscience Engineering from the University of Leuven (Belgium) and has a vast interest in mass spectrometry of small molecules and non-targeted analysis / cheminformatics related topics.
Philippe Verlinde
Technical Advisor
Dr. Verlinde received his Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2009. He worked as a postdoctoral fellow at the University of Leuven (Bioscience Engineering), conducting research in the field of food technology and analytics. From 2010 to 2013 he joined the Institute for Reference Materials and Measurements (IRMM) of the European Commission’s Joint Research Centre as a scientific support officer and was involved in several research projects in the field of method standardization (CEN, ISO), proficiency testing and regulatory aspects of environmental pollutants and food safety. Due to his background, he has gained strong expertise in analytical chemistry, especially in the field of structural elucidation techniques (NMR, MS), method development and validation, and trace analysis by chromatography (GC & LC) hyphenated to mass spectrometry (small molecules). In 2013 he joined Toxikon Europe as an analytical expert and study director at the Pharma Department, focusing on impurity identification projects. Since 2016 he is acting as a senior scientist in the R&D team at Nelson Labs Europe and is involved in automation projects and the development of state-of-the-art analytical services related to extractables and leachables studies for the pharmaceutical and medical device industries.
