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Live Online Conference: Endotoxin and Pyrogen Testing

25 November 2021, 09.00 - 17.30 h CET
26 November 2021, 09.00 - 13.30 h CET

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 2021.

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 - 25 November 2021

Towards an Animal-free Pyrogenicity Testing Strategy in the European Pharmacopoeia
Dr Emmanuelle Charton, EDQM

Inspection Experiences
Dr Rainer Gallitzendörfer, GMP Inpector, Government of Upper Bavaria

Regulatory Perspectives in Europe, USA and Japan on the Validation and Industrial Implementation of the rFC Method
Arnaud Paris, bioMérieux

Sustainability in Bacterial Endotoxin Testing – A Holistic Approach
Veronika Wills, ACC

The Journey of LER
Dr Michael Kracklauer, Microcoat

FDA Perspective on Pyrogen Detection Systems
Dr Reyes Candau-Chacon, FDA

Horseshoe Crab Conservation and Reducing LAL in Testing
Nicola Reid, Charels River Laboratories

Fully Automated, High Speed & High Throughput Endotoxin Testing with the Fluent Gx and rFC
Dr Stefan Haberstock, Tecan

Centripetal Microfluidic Automation for Optimized Endotoxin Testing
David Wadsworth, Suez

Error-Proofing and Futureproofing: Part Deux
Ruth Noe, Lonza

Scalable Generation of Fully Defined Monocyte/Macrophages from Human iPSC to Assess Pyrogens in Parenteral drugs and Medical Products
Prof. Dr. Nico Lachmann, Medical University Hannover

Programme - 26 November 2021

The Monocyte Activation Test (MAT) Can Predict Reactions to Medical Devices in Contact with Blood
Dr Sandra Stoppelkamp, University Tübingen

Waive and Replace the Rabbit Pyrogen Test in Lifecycle Vaccine Release
Dr Shahjahan Shaid, GSK Vaccines

Method Validation Strategy for Endotoxin Testing of Water Samples with Recombinant Factor C in Adherence to 3R Principle for Animal Welfare
Carmen Marín Delgado de Robles, Roche Diagnostics
Viviane Grunert da Fonseca, Roche Diagnostics

From Cell Preparation to ELISA Execution: Key Aspects for a Successful Implementation of the MAT
Dr Eelo Gitz, Sanquin

MAT - Identifying Innate Immune Response Modulating Impurities
Sophia Pfeiffer, Boehringer Ingelheim

Feasibility of the Monocyte Activation Test for Cell-Based Samples
Anne-Clair Erba, Merck

Monocyte Activation Test: Understanding and Mitigating Patient Safety Risks Arising from the Synergistic Effects of Mixed Pyrogens
Shabnam Solati, CTL-MAT

Next-generation Monocyte Activation Test: Increasing Accuracy/Reliability for High Throughput Sample Testing
Dr Koen Marijt, MAT-Research

Speakers

Dr Reyes Candau-Chacon, FDA, USA
Microbiologist in Branch 2 of the Division of Biotechnology Manufactruing (DBM), Office of Pharmaceutical Quality, CDER).

Dr Emmanuelle Charton, COUNCIL OF EUROPE - EDQM & Healthcare, France.
Deputy Head European Pharmacopoeia Department. Head of Division B in the European Pharmacopoeia department at EDQM.

Carmen Marín Delgado de Robles, Roche Diagnostics, Spain
Quality Control Scientist Endotoxins.

Anne-Claire Erba, Merck, France
Senior R&D Scientist.

Dr Rainer Gallitzendörfer, Government of Upper Bavaria, Germany
GMP Inspector.

Dr Eelo Gitz, Sanquin Reagents, The Netherlands
Head Product Development.

Dr Stefan Haberstock, Tecan, Germany
Senior Market Manager Detection & Liquid Handling EMEA.

Dr Michael Kracklauer, Microcoat Biotechnologie, Germany
Manager Endotoxin Services.

Prof. Dr. Nico Lachmann, Medical University Hannover, Germany
Group leader at the “REBIRTH Research center for translational and regenerative medicine”.

Dr Koen Marijt, MAT Research, The Netherlands
Co-founder.

Ruth Noe, Lonza Bioscience, UK
Senior Product Manager.

Arnaud Paris, bioMérieux, France
Director of Scientific Affairs.

Sophia Pfeiffer, Boehringer Ingelheim, Germany
Expert Rapid Microbiological Methods.

Nicola Reid, Charles River Laboratories, UK.
Associate Director of Endotoxin Products.

Dr Shahjahan Shaid, GSK Vaccines, Germany
Senior Manager.

Shabnam Solati, CTL-MAT, The Netherlands
CEO.

Dr Ingo Spreitzer, Paul-Ehrlich-Institut, German Federal Agency for Vaccines and Biomedicines
Deputy Head at PEI and Chair EDQM Working Party "Bacterial Endotoxin Test.

Dr Sandra Stoppelkamp, University Tübingen, Germany
Expert MAT Medical Devices.

David Wadsworth, Suez Water Technologies & Solutions, Analytical Instruments, USA
Product Management.

Veronika Wills, Associates of Cape Cod, USA
Manager Technical Services.