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: 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.

Both technologies with crucial advantages for end users will be presented at the Microbiology seminar day 19th of February in Hamburg Germany.

Short CV Silvia Scotti:

Silvia graduated in Pharmaceutical Chemistry and Technologies in Milan in 2001 with focus on analytical chemistry and method development. She started working in Novuspharma SpA in Monza in 2001 as R&D scientist and then moved to Boston Scientific Ireland in 2006. Silvia has joined Eurofins BioPharma Product Testing Italy in 2008 and she has internally covered different positions such as Pharma Project Leader and Studies Laboratory Manager. She contributed to the start-up of the new Biologics Business Unit in 2018 as Business Unit Manager and since 2021 she is managing strategic projects mainly focused on innovation, automatisation and digitalisation. The implementation of the new rapid sterility method in microbiological pharma laboratories is one of the projects she has recently managed as Senior Project Manager in collaboration with internal microbiological experts and external stakeholders.

Short CV Simone Bertolacci: 

Simone graduated in Medical Biotechnology in Milan in 2005 with thesis and internship focus on viral safety. After a short term fellowship at the center for research in infectious disease at the University Collage of Dublin he joined Eurofins BioPharma Product Testing in 2007 and contributed to develop the biotechnology laboratory in the Italian site and he managed it within the Pharma Business Unit from 2015 to 2018. He contributed to the start-up of the new Biologics Business Unit in 2018 as manager of microbiology and molecular biology laboratory and in 2021 has been involved in the activation of the new facility dedicated to Biologics testing and now manages all the teams dedicated to biosafety, from microbiology and sterility testing to all the analytical lines related to molecular biology techniques.