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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
Alternative methods for endotoxin detection – an equivalence study for the evaluation of a rFc based method
Stefan Gärtner, Labor L+S
From First Evaluation to a Representative Endotoxin Test: a Story about
Dr Jan Erik Rau, Lonza
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?
- 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
- Assay variability and invalidity rates
(1→3)-β-D-Glucan: A biological response modifier found as a contaminant in pharmaceuticals
Veronika Wills, ACC
Requirements of JP
Yutaka Kikuchi, National Institute of Health Sciences
LPS Structure
Fred Caroff, LPS Bioscience
Comparative Study MAT, BET, biophysical analytics
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, such as Bexsero.
- Implementation of the MAT as release testing for Bexsero in replacement of the canonical animal-based pyrogen tests (RPT and LAL)
- Demonstration of a significant correlation between MAT values and LAL and RPT
- 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
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: ensuring patient safety and product quality
- Monocyte activation test: the human in vitro alternative to Rabbit Pyrogen Test
- Cell line-based MAT: key benefits and performances
- Case study on various matrices: product specific validation and routine testing
Healthy human immune cells as pyrogen detection source and advancement of drug release testing
Shabnam Solati, MAT Biotech
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
Dr Barbara Capecchi, GSK
Senior Manager
Fred Caroff, LPS Bioscience
Wilmar Correa, Research Center Borstel
John Dubczak, Charles River Laboratories
General Manager Microbioal Solutions Division
Dr Anja Fritsch, Confarma
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
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, Inc:
Assistant Manager of Technical Services
Dr Friedrich von Wintzingerode, Roche Diagnostics