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Live Online Conference: Endotoxin and Pyrogen Testing
10 and 11 November 2020
This Live Online 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
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 2020.
This Live Online Conference is addressed to all persons from
- Pharmaceutical manufacturers
- Biopharmaceutical companies
- Contract laboratories
- Tissue establishments
who are involved in Endotoxin- and Pyrogen Testing.
Programme - 10 November 2020
09.00 - 09.30 h
Introduction and Organisationals
09.30 - 10.15 h
Key Note: Current European Pharmacopoeia Developments, with a Focus on Microbiology
Dr Emmanuelle Charton, EDQM, Head of Divison B
10.15 – 10.45 h Break
10.45 – 11.15 h - Invention of rFC
Prof. Jeak Ling Ding, National University of Singapore
11.15 – 11.45 h - Evaluation of rFC
Sophia Pfeiffer, Boehringer Ingelheim
11.45 – 12.15 h - The Changing BET Landscape and the Recombinant Alternative
Veronika Wills, Associates of Cape Cod.
12.15 – 12.45 h - Questions and Answers
12.45 – 13.45 h Break
13.45 – 14.15 h - Data as clean as Water: The Criticality of Detecting Relevant Endotoxins in Global Pharmaceutical Water Samples
Nicola Reid, Charles River Laboratories
14.15 – 14.45 h - Symbols of Infection
Kevin Williams, BioMerieux
14.45 – 15.15 h - ,,Error-proofing” and “Future-proofing”:
Updating the Bacterial Endotoxins Test with Automation and Recombinant Reagents
Ruth Noé, Lonza
15.15 – 15.30 h Break
15.30 – 16.00 h - Masking of Endotoxin during Sample Hold Time
René Ørving, Novo Nordisk
16.00 – 16.30 h - How to deal with rFC?
Dr Ingo Spreitzer, Paul-Ehrlich Institut (PEI)
16.30 – 17.00 h - Questions and Answers
Programme - 11 November 2020
09.00 - 09.45 h
Key Note: RTRT: A Reality Check in the Small and Large Molecule World
Dr Lorenz Liesum, F. Hoffmann-La Roche
09.45 – 10.30 h
The Endotoxin Hypothesis of Neurodegeneration
Professor Guy C. Brown, Department of Biochemistry, University of Cambridge
10.30 – 11.00 h
Use of Monocyte Activation Test for Evaluation of Pyrogenicity associated with typical Environmental Contaminants
Dr Anja Fritsch, Confarma
11.00 – 11.15 h Break
11.15 – 11.45 h
Improving the Robustness of MAT Testing by understanding Donor Variability
Koen Marijt, MAT Research
11.45– 12.15 h
Pyrogen Detection on Cellular Prepartions and other Short Shelf Life Pharmaceuticals
Stefan Gärtner, Labor LS
12.15 – 12.45 h
Questions and Answers
12.45 – 13.45 h Break
13.45 – 14.15 h
Using the Monocyte Activation Test to determine the Pyrogenicity of an OMV Vaccine
Dr Marijke Molenaar-de Backer, Sanquin
14.15 – 14.45 h
The Monocyte Activation Test (MAT): The Road forward for Pyrogen Testing
Shabnam Solati, CTL-MAT
14.45 – 15.15 h
Pyrogenic activation measured in the MAT: Is it always related to contaminants?
Dr Sandra Stoppelkamp, University Hospital Tübingen
15.15 – 15.30 h Break
15.30 – 16.00 h
The Truth of Endotoxin Values - Points for Consideration During Investigation of Aberrant BET Results
Dr Johannes Delp, Microcoat Biotechnologie
16.00 – 16.30 h
Endotoxin OOS, OOT and Atypic Results – the ECA Guide on Microbiological Deviation Chapter 2
Jordi Iglesias, Charles River Laboratories
16.30 – 17.00 h
Questions and Answers
Dr Johannes Reich, Microcoat Biotechnologie
Professor Guy C. Brown, University of Cambridge
Department of Biochemistry. Professor of Cellular Biochemistry at the
Dr Anja Fritsch, Confarma, France
Responsible for cell based bioassays (development and routine).
Stefan Gärtner, Labor LS, Germany
Head of Department - Sterile Products Rapid and Alternative Methods.
Jordi Iglesias, Charles River Laboratories, Ireland
Technology Market and Development Manager.
Professor Jeak Ling Ding, National University of Singapore
Professor at Department of Biological Sciences.
Koen Marijt, MAT Research, The Netherlands
Senior Immunology Scientist.
Dr Marijke Molenaar-de Backer, Sanquin, The Netherlands
Manager MAT services.
Ruth Noé, Lonza, UK
Senior Product Manager.
René Ørving, Novo Nordisk, Denmark.
Sophia Pfeiffer, Boehringer Ingelheim, Germany.
Nicola Reid, Charles River Laboratories, UK
Associate Director Product Management.
Dr Ingo Spreitzer, Paul-Ehrlich-Institut, German Federal Agency for Vaccines and Biomedicines
Deputy Head of Section 1/3, “Microbial Safety and Parasitology”.
Dr Sandra Stoppelkamp, University of Tübingen and South Westphalia University of Applied Sciences, Germany
Shabnam Solati , CTL-MAT, USA
Chief Executive Officer.
Veronika Wills, Associates of Cape Cod, USA
Manager Technical Services.
Kevin Williams, bioMérieux, USA
More speakers to be added