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Endotoxin and Pyrogen Testing
20 and 21 November 2018
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 2018
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
Current US Regulation and FDAs Thinking
Jessica Hankins, FDA
PDA LER Technical Report Scope, Overview, Impact on Industry
Dr Friedrich von Wintzingerode, Roche
The Evolution of Endotoxin Test
Kevin Williams, bioMerieux
- Advent of biologics
- Fever and biologics
- A modern biologics microbiological context
- Advent of recombinant Factor C
- Future considerations
LER – An alternative Explanation
John Dubczak, CRL
Pyrogenicity of Food Supplements - Comperative Study of MAT, BET and rFC
Stefan Gärtner, Labor LS
- The issue of orally taken LPS-containing food supplements and immune-stimulants
- Testing of Pyrogenocity using MAT, BET and rFC
- Conclusions
From First Evaluation to a Representative Endotoxin Test: a Story about Masking
Dr Jan Erik Rau, Lonza
- Relevant definitions
- Expectations (internal and external)
- Case study: step by step to a representative test
- Lessons Learned
An approach to LER (Low Endotoxin Recovery) & Update of EP chapter 5.1.10
Hans Noordergraaf, Abbott
- LER Phenomenon and implications for Influenza vaccine
- Study to execute with NOE or RSE?
- Results RSE LER study
- Proposal 5.1.10 change : comments to EP proposal
- New chapter requires Risk Assessment to conclude BET or MAT as reference method
- Risk Assessment detailed execution for Influenza vaccine process form Egg to Syringe
- Issues to implement MAT for a viral vaccine
- Conclusion
Evaluation of new solutions for endotoxin testing for water samples
Marine Marius, Sanofi Pasteur
- Comparison of LAL-based and new rFC assays
- Assay Duration
- results in IU/mL
- PPC recovery
- Assay variability and invalidity rates
(1→3)-β-D-Glucan: A biological response modifier found as a contaminant in pharmaceuticals
Veronika Wills, ACC
- Description and sources of glucans
- Biological effects of glucans
- Glucan quantification
- Case studies documenting glucan contamination
- Biologics manufacturing approaches
Requirements of JP
Yutaka Kikuchi, National Institute of Health Sciences
LPS Structure
Martine Caroff, LPS Bioscience
Biophysical interpretation of a systematic comparison of MAT and BET for LER understanding
Wilmar Correa, Research Center Borstel
Pyrogen and Endotoxin Testing – Where do we go?
Dr Ingo Spreitzer, PEI, German Federal Agency for Vaccines and Biomedicines
- testing for pyrogens or for Endotoxin?
- Pyrogens: MAT in its variations
- intrinsic pyrogenicity; new chapter under development
- Endotoxins: relevance of standard vs. NOE-preparations; regulation vs. science
- current issues in detecting endotoxin and Non Endotoxin pyrogens
- rFC: current situation
- will I see the day that it becomes compendial (I´m 51 years old …), ?
Monocyte Activation Test for predicting pyrogenic content in vaccines without animal models
Dr Barabara Capecchi, GSK
- Development and validation of the Monocyte Activation Test using human PBMC to reliably quantify endotoxin and non-endotoxin pyrogens in a vaccine with intrinsic pyrogenicity
- Demonstration of a significant correlation between MAT values and LAL and RPT
- Implementation of the MAT as release testing for Bexsero in replacement of the canonical animal-based pyrogen tests (RPT and LAL)
- Additional applications of MAT as limit test to assess the absence of exogenous pyrogens in non-pyrogenic vaccine
Challenges in applying the Monocyte Activation Test for routine testing in the QC environment
Dr Ruth Röder, Microcoat
- MAT - Current regulatory perspectives
- Non endotoxin pyrogens – Standards for MAT needed
- How to choose the right cells - Sources and their variability
- Read-out of cytokines and their interpretation
Pyrogen detection with the cryopreserved PBMC-based MAT Cell Set: performance, study examples and challenges
Dr Eelo Gitz, Sanquin
- Characteristics and performance of Sanquin Reagents MAT Cell Set
- Examples of validation and drug release testing of plasma derived products
- Other critical aspects and tips for performing MAT
Pyrogen detection with the MM6 cell-line: implementation as a routine test.
Mathilde Arnault/Dr Anja Fritsch, Merck/Confarma
- Pyrogen testing: taking Non Endotoxin Pyrogens into consideration for patient safety
- Pyrogen testing and the 3Rs: replacing animal-based methods by Monocyte Activation Test
- Cell line-based MAT: key benefits and performances
- Validation of the MM6 cell-line based MAT: a robust and sensitive method
- How to implement cell-line based MAT in routine testing: example with different matrices
Healthy human immune cells as pyrogen detection source and advancement of drug release testing
Shabnam Solati, MAT Biotech
- An end-to-end process: MAT kit generation, test performance and product-specific validation
- Presenting the solution to recent EP criteria: MAT as risk assessment for the endotoxin test and replacement of RPT
- Advancing human health by maximising contamination detection capabilities
- The solution for pyrogenicity tests of medical devices
Moderation
Dr Friedrich von Wintzingerode, Roche Diagnostics GmbH Penzberg, Germany
Senior Manager QC Microbiology. Lead of Endotoxin Expert Group Roche/Genentech.
Speakers
Mathilde Arnault, Merck
Research Scientist - BioMonitoring R&D.
Dr Barbara Capecchi, GSK
Senior Manager in Analytical Research and Development.
Martine Caroff, LPS Bioscience
Wilmar Correa, Research Center Borstel
Chief Scientific Officer.
John Dubczak, Charles River Laboratories
General Manager Microbioal Solutions Division.
Dr Anja Fritsch, Confarma
Responsible for cell based bioassays (development and routine).
Stefan Gärtner, Labor LS
Dr Eelo Gitz, Sanquin Reagents
Project manager product development.
Jessica Hankins, FDA
Marine Marius, Sanofi Pasteur
Scientist in Analytical R&D Microbiology.
Hans Noordergraaf, Abbott Biologicals
Global Microbiological Expert.
Dr Ruth Röder, Microcoat
Project Manager Endotoxin Services.
Dr Jan Erik Rau, Lonza AG
Head of QC Microbiology.
Dr Ingo Spreitzer, Paul-Ehrlich-Institute
Deputy Head of Section 1/3, “Microbial Safety and Parasitology”.
Shabnam Solati, MAT BioTech BV
Co-founder and Lead scientist.
Kevin Williams, BioMerieux
Veronika Wills, Associates of Cape Cod
Assistant Manager of Technical Services.
Dr Friedrich von Wintzingerode, Roche Diagnostics
Senior Manager Microbiology, Head of Roche/Genentech global Endotoxin Expert Group and Roche/Genentech global SME on microbial product contaminations.