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Live Online Conference: Endotoxin and Pyrogen Testing

10 and 11 November 2020

Objectives

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

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 2020

Target Audience

This Live Online Conference is addressed to all persons from

  • Pharmaceutical manufacturers
  • Biopharmaceutical companies
  • Contract laboratories
  • Tissue establishments
  • Authorities

who are involved in Endotoxin- and Pyrogen Testing.

Programme - 10 November 2020

09.00 - 09.30 h
Introduction and Organisationals

Congress Keynote 10.11.2020: Current Pharmacopoeial Developments with Relevance on Microbiology

09.30 - 10.15 h
Key Note: Current Pharmacopoeial Developments with Relevance on Microbiology
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, Singapore

11.15 – 11.45 h - Evaluation of rFC
Speaker Boehringer Ingelheim invited

11.45 – 12.15 h - The Changing BET Landscape and The Recombinant Alternative
Veronika Wills, Associates of Cape Cod.

12.15 – 12.45 h - Question 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 - Impact of sample preparation on endotoxin detection
Speaker Invited

15.15 – 15.30 h Break

15.30 – 15.45 h - Masking of endotoxin during sample hold time
Rene Orving, Novo Nordisk

15.45 – 16.15 h - FDAs Thinking on Current Developments in Endotoxin and Pyrogen Testing
Patricia Hughes, FDA (invited)

16.15 – 17.00 h - Question and Answers

Programme - 11 November 2020

Congress Keynote 11.11.2020: Challenges in Analytical QC

09.00 - 09.45 h
Key Note: Challenges in Analytical QC
Dr Lorenz Liesum, Roche (invited)

09.45 – 10.30 h
Overcoming Technical Issues with Assays to Assess Innate Immune Response Modulating Impurities
Daniela Verthelyi, MD, PhD., U.S. Food and Drug Administration, Chief Laboratory of Immunology, CDER

10.30 – 11.00 h
The endotoxin hypothesis of neurodegeneration
Professor Guy C. Brown, Department of Biochemistry, University of Cambridge

11.00 – 11.15 h Break

11.15 – 11.45 h
Use of Monocyte activation test for evaluation of pyrogenicity associated with typical environmental contaminants
Dr. Anja Fritsch, Confarma

11.45– 12.15 h
Pyrogen Detection on cellular prepartions and other short shelf life pharmaceuticals
Stefan Gärtner, Labor LS/em>

12.15 – 12.45 h
Questions and Answers

12.45 – 13.45 h Break

13.45 – 14.15 h
Determination of Pyrogens from Medical Devices/MAT Multiplexing
Dr. Wolfgang Rudy, Tentamedix

14.15 – 14.45 h
Using the Monocyte Activation Test to determine the pyrogenicity of an OMV vaccine
Dr. Marijke Molenaar-de Backer, Sanquin

14.45 – 15.15 h
The Monocyte Activation Test (MAT): The road forward for pyrogen testing
Shabnam Solati, CTL-MAT

15.15 – 15.30 h Break

15.30 – 16.00 h
Indutrials Experiences with MAT
Speaker invited

16.00 – 16.30 h
How to handles Endotoxin OOS, OOT and Atypic Results – the ECA Guide on Microbiologival Deviation Chapter 2
Jordi Iglesias, Charles River Laboratories

16.30 – 17.00 h
Questions and Answers