Seminar Microbiology Trends & Comparison Studies!

Speaker: Dr. Harmen Hawer, Head of the Microbiology Laboratory at PANPHARMA GmbH

Talk Title: Advances in Endotoxin Testing

Talk Description: Bacterial endotoxins present a server health risk. Therefore, testing for endotoxins is an essential quality control parameter in the pharmaceutical industry with a crucial role in many release and monitoring processes. Advances in Endotoxin Testing provides a comprehensive overview covering questions on pyrogen and endotoxin risks and detection methods and firsthand experiences with modern detection systems: Why do we need to test for pyrogens/endotoxins? What is the current state of the pharmacopeias? How do different methods compare in terms of performance, stability and other aspects? Why and how to transition effectively to a sustainable testing method?  The content comprises relevant basics for newcomers to the industry as well as detailed information for experienced staff that is looking to stay up-to-date with the most recent developments.

Short CV: Dr. Harmen Hawer is the Head of the Microbiology Laboratory at Panpharma, a producer of injectable medicinal products such as anti-infectives, analgesics, anaesthetics, corticoids and hormones as well as cardio-vascular and neurology medicines. He holds a PhD in microbiology from the University of Kassel, Germany and his core expertise comprises Quality Control processes in the pharmaceutical industry with a focus on microbiological release testing and monitoring methods, validation and development. Dr. Hawer previously managed a technical project to build and qualify a modern WFI generation and distribution system and he is currently active as a free consultant within the pharmaceutical industry offering valuable scientific support for GMP-/Quality- and technical projects.  

Speaker: Dr. Nicole Rieth, Head of ATMP and Biologics Testing, Eurofins BioPharma Product Testing Germany

Talk Title: Implementation of the Monocyte Activation Test as a Replacement of the Rabbit Pyrogen Test – Case Studies of different approaches

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.

Speaker: Olaf Degen, Director Industry Microbiology at Brucker Daltonics

Talk Title: Rapid identification of bacteria and fungi using advanced MALDI-TOF MS methods

Short CV: Olaf Degen is the Director of Industry Microbiology at Bruker Daltonics, BMID, Bremen. Previously, he led Operational Marketing at Biotecon Diagnostics, Potsdam. He studied Microbiology at Freie Universität Berlin and earned an MBA from Kellogg Business School (USA) and WHU Vallendar. He is also a member of the DIN working group on water microbiology.

Talk Description: The MALDI Biotyper® is a rapid microbiological method for identification based on the unique proteomic fingerprint of a microorganism. Proteomic patterns of unknown microorganisms, acquired by Matrix-Assisted Laser Desorption/Ionisation Time-Of-Flight Mass Spectrometry (MALDI-TOF MS), are compared to an extensive, ready-to-use reference library that covers thousands of species. The MALDI Biotyper Reference Library covers Gram-positive and Gram-negative bacteria, even demanding microorganisms like anaerobic and non-fermenting bacteria, can be identified with one approach.

Additionally, specific libraries for filamentous fungi and mycobacteria are also available. The metadata of the MALDI Biotyper Reference Library facilitate the access to taxonomical information, such as synonyms and taxonomical modifications. Overall, the resolution is an important performance parameter in MALDI-TOF mass spectrometry. A high resolution is desired for more precise analysis of samples, as it refers to the ability to distinguish between two closely spaced peaks in a mass spectrum.

Speaker: Faranak Hejabi, Laboratory technician Microbiology, Eurofins BioPharma Product Testing Germany

Talk Title: Beyond Visible Safety: Ensuring Microbial Quality in Non-Sterile Pharmaceuticals

Talk Description: In the pharmaceutical industry, ensuring the microbiological quality of non-sterile products is just as critical as sterile manufacturing. While these products are not required to be completely free of microorganisms, they must not contain harmful pathogens that could endanger patient health. Contamination with specified microorganisms can lead to serious infections, regulatory non-compliance, and costly product recalls. This is why regulatory bodies, including the European Pharmacopoeia (Ph. Eur.) 2.6.13, have set strict guidelines for Microbial Enumeration Tests and Tests for Specified Microorganisms to ensure patient safety and product integrity.

Short CV: Faranak holds a Bachelor's degree in Biotechnology from Kharazmi University of Tehran, obtained in 2021. Since then, Faranak has collaborated with several national and international research groups, contributing to various projects in pharmaceutical and biomedical sciences, resulting in multiple publications in high-impact journals. Her experience includes specialized techniques such as antimicrobial efficacy testing and cell-based assays. In 2024, Faranak joined Eurofins BioPharma Product Testing Hamburg GmbH as a Laboratory Technician in the Microbiology department.

Speaker: Silvia Scotti, Senior Project Manager & Simone Bertolacci, Biotech Laboratory Manager at Eurofins BioPharma Product Testing Italy

Talk Title: RAPID STERILITY METHODS: Eurofins experience with BactAlert for cellular products and new RedOne technology for traditional drug products

Talk Description: Eurofins Biopharma Product testing Italy offers services and expertise on rapid sterility methods to support the manufacturing and the control of sterile medicines. Rapid methods guarantee fast time to result (TTR) and significant benefits such as improving patient safety, allowing an earlier product release and reduction of storage costs.

Additionally, higher reliability and data integrity compliance are fulfilled by the instrumental methods compared to visual methods.  

EBPT Italy has consolidated experience on the use of BactAlert for the sterility of cellular matrices in accordance with Eur Ph 2.6.27 and has recently enlarged its panel of tests with the validation of a rapid alternative method to Eur Ph 2.6.1 for traditional products using the RedOne technology. Time to results of 7 days or 4 days can be generally expected for sterility test on BactAlert and RedOne respectively, to be anyhow experimentally demonstrated during product specific method suitability.

Short CV Silvia Scotti: Silvia graduated in Pharmaceutical Chemistry and Technologies in Milan in 2001, focusing on analytical chemistry and method development. She joined Eurofins BioPharma Product Testing Italy in 2008, holding roles such as Pharma Project Leader and Studies Laboratory Manager. Since 2021, she has been leading strategic projects in innovation, automation, and digitalisation, including the implementation of rapid sterility methods in microbiological laboratories.

Short CV Simone Bertolacci: Simone graduated in Medical Biotechnology in Milan in 2005, specialising in viral safety. He joined Eurofins BioPharma Product Testing in 2007 and played a key role in developing the biotechnology laboratory. Since 2021, he has been managing biosafety teams across microbiology, sterility testing, and molecular biology, contributing to the activation of a new biologics testing facility.