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Endotoxin and Pyrogen Testing

7 and 8 November 2017

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 2017

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.

Programme

FDA’s current Thinking on Endotoxin Testing and LER
Dr. Patricia Hughes, FDA

Endotoxin and LER Case Study
Dr. Tim Sandle, BPL

Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay
Dr. Ruth Daniels, Janssen

  • Endotoxin hold time studies to identify LER
  • In silico assessment of interfering factors and associated LER mitigation strategies
  • Case study: optimization of product-specific LAL assay to overcome LER

LER effect shown at a multi-vitamin solution
Dr. Michael Rieth, Merck

  • Validation of the Bacterial Endotoxin Test (BET) for a multi-vitamin solution
  • Ultrafiltration step for removing endotoxins
  • LER when performing the BET
  • LER when performing MAT
  • Comparison with another multi-vitamin solution which shows no LER effect

Microbial Contamination Control that includes an Immunological Context
Kevin Williams, BioMerieux

  • Microbial Contamination Control that includes an Immunological Context
  • Fever is common in biologics administration
  • Beyond Fever: Immunological context
  • Hidden Endotoxin (LER + Protein-Endotoxin Binding)

Influence of origin and culturing method of Natural Occuring Endotoxins on Endotoxin Masking for the LAL and the MAT assay
Peter Cornelis, Toxikon

  • Significant effects of the culturing method and the origin of NOE's on masking effects
  • The data for 8 different species and three culturing methods
  • Comparison of Masking effects between the MAT and the LAL assay

Case Studies on Endotoxin Masking from a CMO
Dr. Jan Erik Rau, Lonza

  • Case Studies on LER
  • Case Studies on Protein Masking
  • Demasking Strategies
  • Possible Release Strategy for Product showing LER and Protein Masking on BDS

Biologics Production: Safety and product quality aspects of bioburden contaminations of non-sterile process intermediates
Dr. Friedrich von Wintzigerode, Roche

  • Microbial Risk of Biologics Large Scale production
  • Microbial PAMPs and toxins as critical components (CCAB approach)
  • CCAB calculations
  • Assessment of risk potential

Latest challenges in the field of endotoxin and pyrogen testing
Dr. Johannes Reich, Microcoat

  • Comparison of different test methods
  • Detection of endotoxin out of LER conditions
  • Case study: Evaluation of a demasking protocol

Regulatory view on MAT
Dr. Ingo Spreitzer, Paul-Ehrlich-Institut, Germany Agency for Vaccines and Biomedicines

  • Why testing for pyrogens / Endotoxins?
  • MAT today
  • Intrinsic pyrogenicity
  • Current issues in detecting endotoxin and Non Endotoxin pyrogens

Comparing key performance aspects of different MAT technologies
Shabnam Solati, MAT Research

  • Comparing the different MAT systems on sensitivity, reproducibility, robustness, availability and specificity. What does the data say?
  • Regulative developments in the EU concerning pyrogen testing and the MAT. Wheredo you start?
  • Endotoxin Masking and Low Endotoxin Recovery. Is there a role for MAT in resolving this problem?

Detection of pyrogens with MAT Cell Set, a highly sensitive Monocyte Activation Test based on pooled PBMC
Dr. Astrid Visser, Sanguin

  • Characteristics and performance of MAT Cell Set from Sanquin
  • Examples of validation and drug release testing of plasma derived products
  • Critical aspects and tips for performing MAT

Evaluation of the monocyte activation test for the safety testing of meningococcal B vaccine Bexsero: a collaborative study
Dr. Karin Nordgren, National Institute of Standards and Control (NIBSC)

  • Quantifying pyrogenic content of an inherently pyrogenic vaccine using the MAT
  • Collaborative study with 9 participating laboratories, covering a range of cell sources and read-outs
  • Application of Ph. Eur. Chapter 2.6.30 Method C: Reference Lot Comparison Test

The Monocyte activation test in routine quality control
Dr. Anja Fritsch, Confarma

  • Testing with Cell Lines
  • Use in Routne Qiality Control

Importance Of Data Integrity When Testing For Endotoxin
Robert Porzio, Lonza

  • Data Integrity Basics and Corporate Governance from the FDA
  • Introduction to Kinetic Testing with emphasis on observations of subjective test methods
  • Data Integrity components through WinKQCL™ Endotoxin Detection & Analysis Software
  • Establishing a Risk Based Approach to your review process flow through Audit Trails
  • Document assay process flow from sample preparation to review and release of results

Moderation

Friedrich von Wintzingerode, Roche Diagnostics GmbH Penzberg, Germany
Senior Manager QC Microbiology. Lead of Endotoxin Expert Group Roche/Genentech.

Speakers

Dr. Ruth Daniels, Janssen, Belgium
Senior Scientist, SME micro. Member of BPOG Low endotoxin recovery Group, and PDA Low endotoxin recovery task force.

Peter Cormelis, Toxikon, Belgium
R&D scientist and Business Analyst.

Dr. Patricia Hughes, U.S. Food and Drug Administration
Branch Chief (Actg), Division of Microbiology Assessment, OPF/ OPQ/ CDER.

Dr. Anja Fritsch, Confarma, France
Responsible for cell based bioassays (development and routine)

Dr. Karen Nordgren, National Institute of Standards and Control (NIBSC), United Kingdom
Head of the Pyrogen Science Group.

Robert Porzio, Lonza, United States
Global Product Manager. Focusing in instrumentation, automation and software solutions

Dr. Jan Erik Rau, Lonza, Switzerland
Senior Scientist and Lab-Manager.

Dr. Johannes Reich, MicroCoat Biotechnologie GmbH, Germany
Focus on the aggregation and interaction of Lipopolysaccharides as well as the related activities in limulus based detection Systems.

Shabnam Solati, MAT Experiences, The Nederlands
Biomolecular Researcher with 25 years of experience, and Monocyte Activation Test (MAT).

Dr. Ingo Spreitzer, Paul-Ehrlich-Institut, Germany Agency for Vaccines and Biomedicines, Langen, Germany
Deputy Head of Section 1/3, “Microbial Safety and Parasitology”.

Dr. Michael Rieth, Merck, Germany
Department Global Regulatory Affairs

Kevin Williams, BioMerieux, USA
Author of the book “EndotoxinS 2”

Dr. Astrid Visser, Sanquin Blood Supply Foundation, The Netherlands
She coordinates the development of the MAT assay and cells for a robust, reliable Assay.

Dr. Friedrich von Wintzingerode, Roche Diagnostics GmbH, Penzberg, Germany
Senior Manager Microbiology, Head of Roche/Genentech global Endotoxin Expert Group and Roche/Genentech global SME on microbial product contaminations.