Chromatographic Method Development: Key Considerations & Real-World Case Studies
Recorded: Wednesday, April 15 — 11:00 AM -12:00 PM ET
Analytical testing in foods, feeds, pharmaceuticals, nutraceuticals and related products is critical to ensure a product’s purity/potency, safety, efficacy, and to meet regulatory requirements. But what do you do if there are no commercially available tests that meet your needs? There are many reasons why you may need to develop a new method, such as bringing to market a novel new product/active ingredient, changes to your sample matrix or formulation (i.e., formulating as gummy instead of pill), changes to regulations that require lower detection limits or target different impurities, etc. This presentation will cover practical considerations for custom method development with a focus on chromatographic techniques. From the initial steps of deciding on an approach, to in lab development and method validation for routine or regulatory use, the process of method development will be explained using real world case studies and examples.
Presented by Jamie Willems (Eurofins)
Dr. Jamie Willems received her Ph.D. in food chemistry from the University of Saskatchewan and currently works as a Sr. Scientist and the Manager of Special Analysis at Eurofins SFA Laboratories in New Berlin, Wisconsin. She specializes in various chromatographic based techniques (HPLC-PDA, HPLC-MS, HPAE-PAD, GC-FID, GC-MS) and has experience with custom method transfers, method development, suitability studies, method validation and flavor/fragrance analysis.
An Introduction to the New Product Introduction (NPI) Process for Microbiology Methods in Food Safety: A Developer’s Perspective
Recorded: Thursday, May 7 — 11:00 AM -12:00 PM ET
Foodborne pathogen detection is crucial for food safety and public health. Current detection methods of foodborne pathogens from food and environmental samples range from traditional culture-based and immunological assays to rapid molecular techniques like PCR and advanced biosensors. Innovation in this space continues to drive the development of new methods and products that prioritize speed and sensitivity for faster and more accurate results. New Product Introduction (NPI) is the structured process of transforming a concept into a market-ready product. It encompasses multiple stages and cross-functional collaboration, with Research & Development (R&D) serving as a cornerstone. R&D is a foundational phase of the NPI process, focusing on how ideas are transformed into working prototypes through activities like feasibility studies, creating detailed specifications, iterative testing and validation. This phase is critical for identifying potential issues early, reducing risks, ensuring products meet the quality and regulatory standards and laying the foundation for subsequent phases, which include production scale-up and commercialization. This session will provide an overview of the NPI process from an R&D lens and provide insightful strategies into how early-career scientists can model this process for new and emerging assays designed for microbiological analytes in food, food ingredients and environmental testing.
Presented by Lei Zhang (Neogen)
Dr. Lei Zhang is currently a principal scientist in Microbiology R&D Division at Neogen with the responsibility of New Product development, and she plays a major role in launching several pathogen detection kits. Lei received her Ph.D. in Poultry Science in 2002 from Auburn University, focusing on development of prevention and detection methods for Salmonella and Campylobacter from chicken carcasses. Lei worked at University of Georgia and Michigan State University before joining Neogen in 2012. She has worked on food safety related research projects through her entire career. Lei’s research projects involve detection of foodborne pathogens, such as Listeria spp., Listeria monocytogenes, STEC, Salmonella, Campylobacter, etc. and microbial indicators for hygiene and quality, such as toral plate count, E. coli and coliforms. Lei is actively involved in AOAC and is a member of AOAC’s Expert Review Panel (ERP) for Microbiology Methods and working group for Microbial Method Validation Guidance Revision.
Getting Your Method into Official Methods of Analysis: Case Studies for Nutrients & Contaminants
Recorded: Thursday, May 28 — 10:00 – 11:30 AM ET
Official analytical methods are essential in the food industry because they provide standardized, validated procedures that ensure reliable and comparable results across laboratories. They form the basis for verifying compliance with food safety and food labelling regulations, support international trade through harmonized testing, and protect consumers by guaranteeing the quality and safety of their food.
In this webinar, we illustrate, through three examples (below), how a method becomes “official” within the AOAC framework. These examples will walk through the full AOAC officialization process and beyond, from initial method development to single laboratory validation, First Action status, multi-laboratory collaborative studies, Final Action status, and ultimately method reviewing, including matrix extension and method improvement. By describing the key steps involved, we demonstrate how rigorous validation and expert review ensure that official methods are robust, reliable, and fit for their intended purpose. The examples that we will use are as follows:
- AOAC 2021.01: Determination of Galactooligosaccharides in Infant Formula & Adult Nutritionals
- AOAC 2018.06: Total Amino Acids in Infant Formulas and Adult Nutritionals
- AOAC 2023.01: Acrylamide determination in food by LC-MS/MS
Presented by Sean Austin, Aurélien Desmarchelier, and Christophe Fuerer (Société des Produits Nestlé S.A)
Sean Austin studied Applied Chemistry at the Robert Gordon University in Aberdeen (UK). He moved to the Rowett Research Institute in Aberdeen (UK), where he worked on his PhD on the structural characterization of anti-nutritional polysaccharides in wheat, in collaboration with the University of Nottingham (UK). He moved to the National Institute for Biological Standards and Control in South Mimms (UK) to work on an EU project on the development of glycoconjugate vaccines to protect infants against infections with Streptococcus pneumoniae. At the end of the project he moved to the University of Utrecht (The Netherlands) to study the glycosylation of therapeutic glycoproteins produced in transgenic organisms. Sean started at Nestlé Research in 2003, where he is part of a team responsible for developing, validating and supporting the analytical tools Nestlé uses for the analysis of carbohydrates in food products, ingredients, and samples coming from clinical trials. He has co-authored AOAC and ISO methods for fructooligosaccharides and β-galactooligosaccharides in infant formula and is co-author of one of the AOAC first action methods for the analysis of human milk oligosaccharides in infant formula.
Aurélien Desmarchelier. M. Sc., is an analytical chemist specializing in the determination of chemical- and process-contaminants in foods using LC-MS/MS and LC-HRMS systems at Société des Produits Nestlé S.A. in Lausanne, Switzerland. He is the author of 30 peer-reviewed publications in analytical chemistry and food safety. As an active member of AOAC INTERNATIONAL, he has been the author of AOAC Official First Action 2023.01 (Acrylamide in food by LC-MS/MS) and AOAC Official Final Action 2020.04 (Veterinary drugs in food by LC-MS/MS).
Dr. Christophe Fuerer, senior R&D specialist at Société des Produits Nestlé SA, holds an MSc in Biochemistry and a PhD in Biology and Virotherapy. With two decades of experience in mass spectrometry, cellular biology, and biochemistry, he develops protein analysis solutions to enhance understanding of protein function and improve food safety and quality. Christophe is an active participant in multiple international Standards Development Organizations, including AOAC, IDF, ISO, CEN, and USP, where he plays a key role in advancing the standardization of analytical methods across laboratories. He is dedicated to fostering consensus and establishing robust, trusted analytical standards within the food industry, highlighting the significance of collaborative networks and knowledge sharing in developing reliable scientific methodologies.
Developing and Validating Fit-for-Purpose Botanical Identification Methods
Recorded: Wednesday, June 10 — 11:00 AM – 12:00 PM ET
Botanical identity testing is fundamental to the quality and safety of dietary supplements, supporting regulatory compliance, consumer protection, and brand integrity. This presentation will introduce a practical toolbox of botanical identification approaches—including morphological, chemical, and genomic methods—and compare their respective strengths, limitations, and appropriate use cases. Building on this, we will present a fit-for-purpose framework for selecting and developing methods tailored to different botanical materials. Finally, we will review guidelines for evaluating identification method performance, with a focus on Probability of Identification (POI), and discuss challenges and practical solutions for implementing this approach for botanical ID methods validation in routine quality control.
Presented by Zhengfei Lu (Herbalife)
Dr. Zhengfei Lu is a Principal Scientist at Herbalife, where he leads a quality control scientist team focused on analytical method development, validation, and external scientific engagement. He holds a Ph.D. in Experimental Pathology from the University of Southern California (2014) and a medical degree from Peking University (2008), and brings more than 20 years of combined experience in molecular biology and analytical chemistry. Beyond his role at Herbalife, he serves on the USP Expert Committees for Botanical Dietary Supplements and Herbal Medicines (2020–2025) and Non-Botanical Dietary Supplements (2025–2030), and is actively involved in AOAC INTERNATIONAL activities, including serving as a guest editor for the Journal of AOAC INTERNATIONAL. Dr. Lu’s research has been published in peer-reviewed journals including Food Chemistry, Planta Medica, and the Journal of AOAC INTERNATIONAL, and his publications have been cited over 1,000 times in books and journal articles related to food and dietary supplement quality and safety.
