Seminar Day: Quality Control with Eurofins BioPharma Product Testing

Speaker: Brian Short, Global BET Application Specialist at Veolia

Talk Title: Next-Generation Endotoxin Testing: LAL and rCR Equivalence on a Microfluidic Platform

Talk Description: This presentation demonstrates the comparability of traditional LAL and recombinant chromogenic reagents (rCR) for detecting bacterial endotoxins in water and non water samples.  Testing on a microfluidics platform achieved a 90% reduction in reagents while maintaining compliance with USP <85> and EP 2.6.14, JP 4.01, and FDA requirements. 

Data Set #1 tested several pharmaceutical products with both LAL and rCR reagents. Results showed strong comparability with all positive product control recoveries within 50-200% specification and coefficients of variation below 15%. 

Data Set #2, a collaboration with Eli Lilly, evaluated multiple products using multiple LAL vendors and rCR reagents, demonstrating consistent performance across reagent types with comparable naturally occurring endotoxin results. 

Key findings indicate excellent comparability between commercially available LAL and rCR reagents, reduced time to result, valid precision metrics, and capability for adoption multiple endotoxin detection applications across pharmaceutical manufacturing, biopharma, medical device manufacturers, and contract testing laboratories globally.

Short CV: Brian Short is a Global BET Application Specialist at Veolia, providing strategic pharmaceutical endotoxin detection application support for the life sciences industry. With over 20 years of experience working in and with pharmaceutical quality control laboratories, Brian has supervised and supported high-volume in-process and finished product testing, resulting in deep expertise in endotoxin detection instrumentation and software, including installation, qualification, and training. Brian holds a Bachelor of Science degree in Biological Sciences from York College of Pennsylvania and previously held roles with Wyeth and Lonza.

Speaker: Daniel Kellner-Steinmetz, EMEA Applications Specialist at Veolia

Talk Title: Smarter Cleaning Validation: Using TOC and Conductivity for Rapid Verification

Talk Description: This presentation examines the evolution of analytical methods and regulatory guidance  for cleaning validation (CV), highlighting the shift towards risk-based programs, influenced by documents like the revised EU GMP Annex 1. The core discussion focuses on utilizing non-specific methods, specifically Total Organic Carbon (TOC) and Conductivity, as preferred tools for monitoring residual contamination, including APIs, excipients, and cleaning agents. The content details the toxicological approach and provides practical guidance on converting traditional product limits into TOC limits. Furthermore, it outlines a comprehensive, step-by-step process for implementing and validating TOC technology. Finally, the presentation explores the deployment of TOC in Off-Line, At-Line, and On-Line configurations, demonstrating how automation and effective data analysis enhance process understanding, lower risk, reduce costs, and increase manufacturing efficiency. 

Short CV: Daniel Kellner-Steinmetz is the EMEA Applications Specialist at Veolia, with extensive pharmaceutical industry experience since 2009 across quality, manufacturing, training, and regulatory functions. Before joining Veolia, he served as Global Product Quality Lead for several commercial products at Shire (formerly Baxter) in Vienna. He supports customers in implementing and developing Total Organic Carbon (TOC) methods and delivers international seminars, webinars, and training on TOC, Conductivity, water systems, cleaning validation, data management, and Annex 1. Daniel is particularly passionate about cleaning validation, Pharma 4.0, and technologies that enable automation, rapid release methods, and best practices across pharma operations.

Speaker: Felix Harion, Business Development Manager at Eurofins BPT Germany

Talk Title: ADCs - Biological missiles and their demanding quality control

Talk Description: Antibody drug Conjugates have been studied and developed for more than half a century. But what makes them so interesting for cancer therapies? How do they function and how do we assess their functionality by quality control? These complex platforms at the intersection between small and large molecule require an extended testing portfolio compared to monoclonal antibodies ultimately ensuring patient safety.

Short CV: Felix Harion is a Business Development Manager at Eurofins, responsible for the realisation of collaborations from early phase planning to client onboarding.

He oversees and develops long‑term collaborations with clients, especially for ADC testing and EU market release support. From an educational background Felix holds a master’s degree in Biotechnology and Bachelor´s degree in Molecular Biology from Saarland University. Prior to joining Eurofins, he worked for three years as a lead scientist in EU‑funded research projects, where he coordinated laboratory activities and managed scientific communication with non‑scientific stakeholders.

Speaker: Nina Jagmann, Microbiology department within Quality Control at Nordmark Pharma GmbH

Talk Title: Microbiological Quality Control of Products of Biological Origin: Analytical Challenges in TAMC/TYMC Testing and Objectionable Microorganism Assessment

Talk Description: Active substances and medicinal products of biological origin naturally come with an increased microbial load (bioburden). This presents particular challenges for microbiological quality control — both in determining total microbial counts and in detecting specific microorganisms. The challenge lies not only in the sheer number of microbes. Certain species also test the selectivity of culture media and require nuanced expert evaluation. Using concrete practical examples, the presentation highlights typical problem areas and discusses possible strategies for day‑to‑day laboratory work.

Short CV: Nina Jagmann has headed the Microbiology department within Quality Control at Nordmark Pharma GmbH since 2021, where she is responsible for bioburden analysis and hygiene. She entered the pharmaceutical industry in 2018 as a laboratory manager in microbiology at Nordmark. Before that, she spent several years in academia: following her PhD in microbiology in Konstanz, she completed several years of postdoctoral research at the Institute for Molecular Microbiology and Biotechnology in Münster. Today, she is able to bring her passion for microorganisms into the pharmaceutical industry as well.

Speaker: Nicole Rieth, Head of ATMP and Biologics Testing, Eurofins BPT Germany

Talk Title: Next‑Generation Pyrogen Testing: Advancing MAT as the New Industry Standard

Talk Description: The monocyte activation test (MAT) has emerged as an ethical, animal-free alternative for pyrogen testing of pharmaceuticals, replacing traditional methods such as the rabbit pyrogen test (RPT). Introduced into the European Pharmacopoeia in 2010 as alternative, the MAT has become the preferred standard, with full replacement of the RPT targeted by 2025. Eurofins BioPharma Product Testing Germany has established and offers a range of MAT kits that comply with current EP guidelines and are tailored to different needs. These kits use different cell types and readouts to detect both endotoxins and non-endotoxin pyrogens (NEPs) with high sensitivity, accuracy and reproducibility. In particular, a next-generation MAT kit using a reporter gene cell line delivers results within one working day, combining speed with efficiency and accuracy. This advancement underscores the key role of MAT to ensure patient safety while supporting the transition to non-animal testing methods.

Short CV: After her diploma in Biology, with a strong focus on tumor immunology, Nicole Rieth received her PhD from the Ludwig Maximilian University (LMU) in Munich, Germany in 2011. After her work as a senior scientist in a biotechnology company, she held the position of the lead for in vitro pharmacology developing and validating assay formats for proof of concept of two biologic lead candidates at Baxalta and Shire until 2018. She joined Eurofins BioPharma Product Testing Munich in 2018 as a group leader and deputy head of the Immunoanalytics department, further specialising in the development and validation of ELISA, FACS, MSD and cell-based methods. Nicole is currently the Head of the ATMP & Biologics Testing Department.