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Endotoxin and Pyrogen Testing
12 and 13 November 2019
Objectives
This Conference will inform you about current developments in Endotoxin and Pyrogen testing as well as the practical use of established test methods like LAL for Endotoxin testing.
You become informed about
- International regulatory developments
- Feasibility of new and innovative products and methods
- Special issues like masking/LER
- testing of critical substances
- Application of alternative testing methods – MAT or RFC
Background
Testing for Endotoxins and Pyrogens is a critical in-process and final release test for parenteral products. Different approaches have been developed over the last few decades to provide solutions for the breadth of product range that is tested for endotoxins and pyrogens: RPT, LAL, MAT. With the LAL test method as the established, compendial methodology for bacterial endotoxins with harmonization of the EP, USP and JP. Due to the importance of these tests, they are under ongoing scrutiny by industry and regulators to ensure testing efficacy and safe manufacturing and release of products into the market.
Novel medicinal products such as cellular and gene therapies and combinations with medical devices as well as complex biopharma formulations pose testing challenges and require in-depth knowledge and expertise in the field of Endotoxins and Pyrogens. In addition, as the choice of solutions offered by suppliers for endotoxin testing becomes wider (e.g. recombinant factor C, ELISA-based test kits, automated LAL cartridge technology) it is important to get a data driven understanding of the advantages and limitations of each approach.
So not only the discussions on low endotoxin recovery and endotoxin masking are important. Additionally the need for future innovations within BET that provide solutions to current challenges with modern pharmaceutical and biopharmaceutical products for the day-to-day testing should be in our focus.
Enough reasons to attend this Endotoxin and Pyrogen Session at PharmaLab 2019
Target Audience
This Conference is addressed to all persons from
- Pharmaceutical manufacturers
- Biopharmaceutical companies
- Contract laboratories
- Tissue establishments
- Authorities
who are involved in Endotoxin- and Pyrogen Testing.
MAT Task Force
Dr Sven Deutschmann, Roche
Validation of MAT – Regulatory Experiences
Dr Ingo Spreitzer, PEI, German Federal Agency for Vaccines and Biomedicines
Development of the Monocyte Activation Test on vaccines containing inherently pyrogenic components
Stéphanie Richard, Sanofi Pasteur
Comparison of a Monocyte Activation Test based on fetal bovine serum and on human AB serum
Dr Eelo Gitz, Sanquin
Pyrogenicity associated with heat-inactivated microorganisms isolated in our laboratory from actual samples
Dr Anja Fritsch, Confarma
MAT implementation: from validation to use in routine in a GMP QC Lab
Chiara Celli, Merck
MAT - Ready for GMP Routine?
Christiane Höfner, Labor LS
The Monocyte Activation Test: Validation & Analysis
Katrin Pauls, Lonza
Endotoxin, ten misconceptions around detection and control
Kevin Williams, bioMérieux
Current development in Endotoxin and Pyrogen Testing – FDA Point of View
Dr Jessica Hankins, U.S. Food and Drug Administration
Putting Patient Safety First, View from the other side
Milanka Setina, Medicines and Medical Devices Agency of Serbia
Implementing PDA Technical Report on LER in an analytical control strategy
Dr Farnaz Nowroozi, Genentech
Endotoxin and Pyrogen detection of LER Samples
Paul Negwer, PEI, German Federal Agency for Vaccines and Biomedicines
Endotoxins – Requirements of CP
Dr Qing He, Chinese National Institutes for Food and Drug Control
Practical Insights in BET
Dr Jelena Novakovic, Galenika
A Global Perspective for Quantifying All Endotoxins within Pharmaceutical Water Systems
Nicola Reid, CRL
LER – Current Data
Dr Johannes Reich, Microcoat
PyroSmart - a chromogenic recombinant reagent for endotoxin testing
Dr Mizumura Hikaru, Seikagak
Veronika Wills, ACC
Implementation of rFC for product testing
Marine Marius, Sanofi
Moderation
Dr Johannes Reich, Microcoat Biotechnologie
Speakers
Chiara Celli, Merck
Scientist Microbiological ID.
Dr Sven Deutschmann, Roche
Head of Global ASAT "Adventitious Agents Testing and Alternative Microbiologica. Chairman of the Advisory Board of the ECA “Pharmaceutical Microbiology Interest Group”, Member of PDA Task Forces.
Dr Anja Fritsch, Confarma
Responsible for cell based bioassays (development and routine).
Dr Eelo Gitz, Sanquin Reagents
Project manager product development.
Dr Jessica Hankins, U.S. Food and Drug Administration.
Dr Qing He, Chinese National Institutes for Food and Drug Control
Pharmacology Division.
Dr Mizumura Hikaru, Seikagaku.
Christiane Höfner, Labor LS
Senior Expert Microbiological Testing.
Marine Marius, Sanofi Pasteur
Scientist in Analytical R&D Microbiology.
Alexander Negwer, PEI, German Federal Agency for Vaccines and Biomedicines
Scientist Section 1/3, “Microbial Safety and Parasitology”.
Dr Jelena Novakovic, Galenika
Senior Expert Associate.
Dr Farnaz Nowroozi, Genentech
Scientist and Manager - Global Analytical Science and Technology.
Katrin Pauls, Lonza
Market Development and Scientific Affairs Manager.
Dr Johannes Reich, Microcoat Biotechnologie
General Manager.
Nicola Reid, Charles River Laboratories
Senior Product Manager.
Dr Ruth Röder, Microcoat Biotechnologie
Project Manager Endotoxin Services.
Stéphanie Richard, Sanofi Pasteur
Scientist-Analitycal Sciences Department-Immunology platform.
Dr Milanka Setina, National Control Laboratory Medicines and Medical Devices Agency of Serbia
Scientist.
Dr Ingo Spreitzer, PEI, German Federal Agency for Vaccines and Biomedicines
Deputy Head of Section 1/3, “Microbial Safety and Parasitology”.
Veronika Wills, Associates of Cape Cod
Manager Technical Services.
Kevin Williams, bioMérieux
Endotoxin Expert.